Fluoxetine

Product NDC: 65862-193
11-digit product format: 658620193
Labeler code: 65862
Product ID: 65862-193_7dd85e52-3c8c-4ca2-b9fa-0dfaed81123e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078619
Marketing category: ANDA
Marketing start: 2008-01-31
Marketing end: 2028-02-29
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-193		UNFINISHED	Active or certified unfinished drug listing	2026-08-03
unfinished package	package	65862-193	65862-193-26	UNFINISHED	Active or certified unfinished drug listing	2026-08-03
excluded package	package	65862-193	65862-193-05	D	Discontinued by firm	2026-08-03
excluded package	package	65862-193	65862-193-30	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-193-26	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-193-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-193-26	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-193-26	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-193-26	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-193-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-193-26	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-193-26	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-193-26	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-193-26	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-193-26	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-193-26	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-193-26	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-193-26	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-193-26	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-193-26	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-193-26	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-193-26	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-193-26	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-193-26	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-193-26	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078619-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2008-01-31
A078619-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2008-01-31
A078619-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RS	2008-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078619-001	AB1
A078619-002	AB1
A078619-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078619-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078619-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078619-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078619-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluoxetine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I9W7N6B1KJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310384	Internal RxNorm lookup
310385	Internal RxNorm lookup
313989	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45454555-7402-41cb-a452-e6a76e04f387	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9	Product name	6	20250331
e5b459e3-ddce-4802-aab4-2c901d71ae85	Product name	5	20250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464	Product name	3	20240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5	Product name	4	20230104
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-193-01	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100	32
65862-193-05	Fluoxetine	500 in 1 BOTTLE	CAPSULE	500	32
65862-193-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30	32
65862-193-99	Fluoxetine	1000 in 1 BOTTLE	CAPSULE	1000	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-193-01	EA - Each	65862-193	a9e8b438-56c6-49cc-a30e-4fe765e7ac3b	1	2012-07-24
65862-193-05	EA - Each	65862-193	1776f5b9-d408-4786-ba16-3b9df5ff39dd	1	2012-07-24
65862-193-99	EA - Each	65862-193	e4553278-342e-4026-95ec-db93a108a7a0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3978
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [READYMEDS]	15
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MED-HEALTH PHARMA, LLC]	4
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]	3
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AVPAK]	2
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FLUOXETINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-193	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AUROBINDO PHARMA LIMITED]	31	Current NDC, Legacy NDC, 4 package rows	20240215_45454555-7402-41cb-a452-e6a76e04f387.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	American Health Packaging	7bee936b-0130-4a6b-a974-956aef5486d9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	American Health Packaging	9965a672-7842-4926-9063-b76317c74862	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	32afb28a-dc4c-4a7e-9701-1825f805e7df	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	20516384-6517-48be-bd6e-718250878a76	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Unit Dose Solutions, Inc.	54d9f02c-95ea-99b1-e063-6294a90a9140	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	QPharma Inc	50253c6e-de36-05e6-e063-6294a90ad7a8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	992060ee-fb4e-4c6d-9ffe-30902bc63af2	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	PD-Rx Pharmaceuticals, Inc.	5dc20c8f-0d8f-400c-b850-fe1b7e3e75e3	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d7a196b-91de-4753-8bb6-c6d5c668952d	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	b8666383-462d-4a21-8f49-1d572da386d1	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	d1c768b5-64bb-4036-aa92-797b3a5f92eb	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Northwind Health Company, LLC	50369762-c7c3-d58e-e063-6294a90af8df	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	A-S Medication Solutions	679e439a-d955-4b54-8236-a2ccd9a2a10a	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	A-S Medication Solutions	3ce2f189-4386-4d0d-84f6-6d913ad1c09b	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	faf4bc0c-bf65-4a65-8f08-3d800185d6a8	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	BluePoint Laboratories	daf33244-1348-4c34-b44c-9e35d5c48a3e	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	3ccada47-7eb9-285d-5059-06afb4466114	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	bb06af33-8ff7-0b02-0029-d628f62e1382	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310385	FLUoxetine 20 MG Oral Capsule	PSN	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	39
310385	fluoxetine 20 MG Oral Capsule	SCD	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	39
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	39
310384	FLUoxetine 10 MG Oral Capsule	PSN	45454555-7402-41cb-a452-e6a76e04f387	32
310385	FLUoxetine 20 MG Oral Capsule	PSN	45454555-7402-41cb-a452-e6a76e04f387	32
313989	FLUoxetine 40 MG Oral Capsule	PSN	45454555-7402-41cb-a452-e6a76e04f387	32
310384	fluoxetine 10 MG Oral Capsule	SCD	45454555-7402-41cb-a452-e6a76e04f387	32
310385	fluoxetine 20 MG Oral Capsule	SCD	45454555-7402-41cb-a452-e6a76e04f387	32
313989	fluoxetine 40 MG Oral Capsule	SCD	45454555-7402-41cb-a452-e6a76e04f387	32
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	45454555-7402-41cb-a452-e6a76e04f387	32
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	45454555-7402-41cb-a452-e6a76e04f387	32
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	45454555-7402-41cb-a452-e6a76e04f387	32
310385	FLUoxetine 20 MG Oral Capsule	PSN	20516384-6517-48be-bd6e-718250878a76	25
310385	FLUoxetine 20 MG Oral Capsule	PSN	42c4c341-8282-4961-8581-8a0430162559	25
313989	FLUoxetine 40 MG Oral Capsule	PSN	42c4c341-8282-4961-8581-8a0430162559	25
310385	fluoxetine 20 MG Oral Capsule	SCD	20516384-6517-48be-bd6e-718250878a76	25
310385	fluoxetine 20 MG Oral Capsule	SCD	42c4c341-8282-4961-8581-8a0430162559	25
313989	fluoxetine 40 MG Oral Capsule	SCD	42c4c341-8282-4961-8581-8a0430162559	25
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	20516384-6517-48be-bd6e-718250878a76	25
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	42c4c341-8282-4961-8581-8a0430162559	25
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	42c4c341-8282-4961-8581-8a0430162559	25
310385	FLUoxetine 20 MG Oral Capsule	PSN	bb06af33-8ff7-0b02-0029-d628f62e1382	23
310385	fluoxetine 20 MG Oral Capsule	SCD	bb06af33-8ff7-0b02-0029-d628f62e1382	23
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	bb06af33-8ff7-0b02-0029-d628f62e1382	23
310384	FLUoxetine 10 MG Oral Capsule	PSN	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310385	FLUoxetine 20 MG Oral Capsule	PSN	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310384	fluoxetine 10 MG Oral Capsule	SCD	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310385	fluoxetine 20 MG Oral Capsule	SCD	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	19
310385	FLUoxetine 20 MG Oral Capsule	PSN	b70f4505-ff39-4990-bb12-f9c4c1e3510c	15
310385	fluoxetine 20 MG Oral Capsule	SCD	b70f4505-ff39-4990-bb12-f9c4c1e3510c	15
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b70f4505-ff39-4990-bb12-f9c4c1e3510c	15
310384	FLUoxetine 10 MG Oral Capsule	PSN	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310385	FLUoxetine 20 MG Oral Capsule	PSN	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310384	fluoxetine 10 MG Oral Capsule	SCD	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310385	fluoxetine 20 MG Oral Capsule	SCD	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	9
310384	FLUoxetine 10 MG Oral Capsule	PSN	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310385	FLUoxetine 20 MG Oral Capsule	PSN	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310384	fluoxetine 10 MG Oral Capsule	SCD	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310385	fluoxetine 20 MG Oral Capsule	SCD	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	d0d8bba3-60b5-4307-b96b-246218cedf63	8
310385	FLUoxetine 20 MG Oral Capsule	PSN	4ecc3a7a-971d-2572-e054-00144ff8d46c	5
310385	fluoxetine 20 MG Oral Capsule	SCD	4ecc3a7a-971d-2572-e054-00144ff8d46c	5
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	4ecc3a7a-971d-2572-e054-00144ff8d46c	5
310384	FLUoxetine 10 MG Oral Capsule	PSN	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310384	FLUoxetine 10 MG Oral Capsule	PSN	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	FLUoxetine 10 MG Oral Capsule	PSN	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
310385	FLUoxetine 20 MG Oral Capsule	PSN	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
310385	FLUoxetine 20 MG Oral Capsule	PSN	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310385	FLUoxetine 20 MG Oral Capsule	PSN	62c47df4-2c71-437e-b142-bc193f6277f0	4
313989	FLUoxetine 40 MG Oral Capsule	PSN	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	fluoxetine 10 MG Oral Capsule	SCD	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310384	fluoxetine 10 MG Oral Capsule	SCD	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	fluoxetine 10 MG Oral Capsule	SCD	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
310385	fluoxetine 20 MG Oral Capsule	SCD	62c47df4-2c71-437e-b142-bc193f6277f0	4
310385	fluoxetine 20 MG Oral Capsule	SCD	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310385	fluoxetine 20 MG Oral Capsule	SCD	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
313989	fluoxetine 40 MG Oral Capsule	SCD	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	62c47df4-2c71-437e-b142-bc193f6277f0	4
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	76b264ce-2a13-4511-8e21-4ffad0a327f9	4
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	c85063c1-3a0a-4f50-b898-5afd3bd82fbb	4
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	62c47df4-2c71-437e-b142-bc193f6277f0	4
310384	FLUoxetine 10 MG Oral Capsule	PSN	24b0e72d-2dd3-4355-8ba4-6101b127a36b	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	3fb5ac0a-344e-5b94-e054-00144ff88e88	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	24b0e72d-2dd3-4355-8ba4-6101b127a36b	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	cb66a702-7670-4a73-98fb-0e63151a1ffb	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	fc754dff-cecb-fc6b-e053-6394a90ab371	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	50345702-9869-5335-e054-00144ff88e88	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	24b0e72d-2dd3-4355-8ba4-6101b127a36b	3
310384	fluoxetine 10 MG Oral Capsule	SCD	24b0e72d-2dd3-4355-8ba4-6101b127a36b	3
310385	fluoxetine 20 MG Oral Capsule	SCD	3fb5ac0a-344e-5b94-e054-00144ff88e88	3
310385	fluoxetine 20 MG Oral Capsule	SCD	cb66a702-7670-4a73-98fb-0e63151a1ffb	3
310385	fluoxetine 20 MG Oral Capsule	SCD	fc754dff-cecb-fc6b-e053-6394a90ab371	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-193-01	65862019301	100 CAPSULE in 1 BOTTLE (65862-193-01)	100 capsule	2018-01-31	2028-01-31	No	No	Current
65862-193-05	65862019305	500 CAPSULE in 1 BOTTLE (65862-193-05)	500 capsule	2018-01-31	0000-00-00	No	No	Current
65862-193-26	65862019326	2500 CAPSULE in 1 BAG (65862-193-26)	2500 capsule	31-JAN-08				Current
65862-193-30	65862019330	30 CAPSULE in 1 BOTTLE (65862-193-30)	30 capsule	2018-01-31	0000-00-00	No	No	Current
65862-193-99	65862019399	1000 CAPSULE in 1 BOTTLE (65862-193-99)	1000 capsule	2018-01-31	2028-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	REMEDYREPACK INC.	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	26
Fluoxetine	PD-Rx Pharmaceuticals, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	39
Fluoxetine	Bryant Ranch Prepack	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	23
Fluoxetine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-01-21	Human Prescription Drug Label	32
Fluoxetine	REMEDYREPACK INC.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	19
Fluoxetine	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	QPharma Inc \| Aurobindo Pharma Limited \| Northwind Health Company, LLC	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	Major Pharmaceuticals	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	A-S Medication Solutions	2024-10-15	Human Prescription Drug Label	19
Fluoxetine	A-S Medication Solutions	2024-10-09	Human Prescription Drug Label	25
Fluoxetine - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
Fluoxetine	NuCare Pharmaceuticals, Inc.	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	8
Fluoxetine	Lake Erie Medical DBA Quality Care Products LLC	2022-11-16	Human Prescription Drug Label	3984
Fluoxetine	American Health Packaging	2022-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
Fluoxetine	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	9
Fluoxetine	Preferred Pharmaceuticals, Inc.	2022-05-20	HUMAN PRESCRIPTION DRUG LABEL	10
FLUOXETINE	DIRECT RX	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-03-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluoxetine	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Fluoxetine	St. Mary’s Medical Park Pharmacy \| Aurobindo Pharma Limited	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	NuCare Pharmaceuticals,Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2