Fluoxetine

Product NDC: 68788-9223
11-digit product format: 687889223
Labeler code: 68788
Product ID: 68788-9223_9df3a7a1-4702-4f7b-abd0-49d61bbc2613
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078619
Marketing category: ANDA
Marketing start: 2008-01-31
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9223		D	Discontinued by firm	2026-10-15
excluded package	package	68788-9223	68788-9223-3	D	Discontinued by firm	2026-10-15
excluded package	package	68788-9223	68788-9223-6	D	Discontinued by firm	2026-10-15
excluded package	package	68788-9223	68788-9223-9	D	Discontinued by firm	2026-10-15

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 · 48 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	68788-9223-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9223-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9223-6	`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	68788-9223-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9223-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9223-6	`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	68788-9223-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9223-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9223-6	`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	68788-9223-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9223-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9223-6	`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	68788-9223-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9223-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9223-6	`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	68788-9223-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9223-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9223-6	`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	68788-9223-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9223-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9223-6	`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	68788-9223-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9223-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9223-6	`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	68788-9223-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9223-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9223-6	`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	68788-9223-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9223-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9223-6	`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	68788-9223-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9223-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9223-6	`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	68788-9223-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9223-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9223-6	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RS	2008-01-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RS	2008-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RS	2008-01-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078619-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078619-002	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078619-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078619-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078619-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078619-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078619-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078619-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078619-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, 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
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
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	45454555-7402-41cb-a452-e6a76e04f387	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	da6b9b19-2ea1-9a39-e053-2995a90ad730	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	dfae4357-b6f9-9a30-e053-2995a90a2667	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	cb66a702-7670-4a73-98fb-0e63151a1ffb	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	QPharma Inc	fc754dff-cecb-fc6b-e053-6394a90ab371	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Cardinal Health 107, LLC	06394c4b-99f4-4257-bf29-53c170c5a061	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	CouplerLLC	3e111be4-28f0-c290-e063-6294a90a447f	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	4abbd9d9-e9b1-463d-8f39-f3f50d80f58a	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	NorthStar Rx LLC	3e1e767b-66a5-4f38-8142-84d40d447f92	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
FLUOXETINE	FLUOXETINE HYDROCHLORIDE	DIRECT RX	9b8d8da5-8c06-0942-e053-2995a90aa2c9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	42c4c341-8282-4961-8581-8a0430162559	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	2f302db0-1c88-44cf-8258-3c1c60afb5a4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	1226a67f-ec09-42f6-9d1b-9ddd862ea0a0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	50345702-9869-5335-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NorthStar Rx LLC	97960730-432e-4e94-bb4e-62a3157270a8	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	578ca8f8-86eb-4247-a0b3-50c3837a982e	2024-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	08f3c11c-9ba0-4c53-bf31-264725e611ea	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	BluePoint Laboratories	f89a5800-6fdb-4938-a28e-3bf1aeb1c21a	2023-11-30	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9223-3	68788922303	30 CAPSULE in 1 BOTTLE (68788-9223-3)	30 capsule	2008-01-31	0000-00-00	No	No	Current
68788-9223-6	68788922306	60 CAPSULE in 1 BOTTLE (68788-9223-6)	60 capsule	2008-01-31	0000-00-00	No	No	Current
68788-9223-9	68788922309	90 CAPSULE in 1 BOTTLE (68788-9223-9)	90 capsule	2008-01-31	0000-00-00	No	No	Current