Fluoxetine

Product NDC: 45865-378
11-digit product format: 458650378
Labeler code: 45865
Product ID: 45865-378_7df05c31-3cfa-f983-e053-2991aa0ad0e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA076006
Marketing category: ANDA
Marketing start: 2016-09-30
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-378		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-378	45865-378-60	I	Inactivated by FDA		2026-08-17

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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-378-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-378-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-378-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-378-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-378-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-378-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-378-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-378-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-378-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-378-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45865-378-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45865-378-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45865-378-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45865-378-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45865-378-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45865-378-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45865-378-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45865-378-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45865-378-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45865-378-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45865-378-60	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076006-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30
A076006-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076006-001	AB
A076006-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2018-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076006-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2002-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076006-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-04-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076006-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076006-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076006-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076006-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076006-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076006-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076006-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076006-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076006-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076006-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076006-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076006-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076006-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076006-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076006-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076006-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076006-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076006-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076006-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076006-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076006-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076006-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076006-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076006-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076006-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076006-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076006-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076006-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076006-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076006-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076006-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076006-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076006-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076006-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076006-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076006-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076006-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076006-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076006-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076006-002	AB	1	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-378-60	2020-01-31	C162847	48780-1	9d75b9d0-a15f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral use Initial U.S. Approval : 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-378-60	Fluoxetine	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-378	FLUOXETINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20181227_7df05c31-3cf9-f983-e053-2991aa0ad0e8.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Dr.Reddy's Laboratories Limited	11544dea-2f5e-1536-584a-5d1f37a99770	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076006 application number: ANDA076006
Fluoxetine	FLUOXETINE	Dr.Reddy's Laboratories Inc.	390c61e6-14dd-4391-45b8-0fb5f4652723	2023-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076006 application number: ANDA076006
Fluoxetine	FLUOXETINE	NorthStar Rx LLC	70b4bd1b-d355-189e-a414-9fff182fd1cd	2023-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076006 application number: ANDA076006

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE
01K63SUP8D	FLUOXETINE	54910-89-3	Fluoxetine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313990	FLUoxetine HCl 10 MG Oral Tablet	PSN	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2
313990	fluoxetine 10 MG Oral Tablet	SCD	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2
313990	fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral Tablet	SY	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-378-60	45865037860	60 in 1 BOTTLE	Historical