Fluoxetine

Product NDC: 0904-5785
11-digit product format: 009045785
Labeler code: 0904
Product ID: 0904-5785_7eb87c3e-6bbc-4e57-a560-0d439a4e102b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA076001
Marketing category: ANDA
Marketing start: 2007-02-16
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-5785		D	Discontinued by firm		2026-08-03
excluded package	package	0904-5785	0904-5785-61	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0904-5785		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5785	0904-5785-61	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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
A076001-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2002-01-29
A076001-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2002-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076001-001	AB1
A076001-002	AB1

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 · 82 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	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076001-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	AB1	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5785-61	EA - Each	0904-5785	25c67454-e2c9-4f5b-94fc-a15bdd88902e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [CARDINAL HEALTH]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5785	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	16	Legacy NDC	20240910_0d97a780-be38-4f5e-ba45-d3b5be262c63.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	24926986-7552-4f1a-8366-f035bbd07104	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	1a2a5194-b793-4c62-a177-040dad38526b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	a1b40d46-5233-49d7-9833-762cb6999012	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Northwind Health Company, LLC	4dee4a1a-360c-532e-e063-6394a90a8426	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Legacy Pharmaceutical Packaging, LLC	b07f9eab-44ac-4667-bd46-52d736daa5d6	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	QPharma Inc	b4831735-6731-473a-b4f0-1f4a67aa7120	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	647e17f5-a15a-4e77-922c-24a5db2118bc	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	cece294b-c414-4832-a8a2-22fb66aabda9	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	5631bb72-798a-6efc-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	78994632-74b3-951c-e053-2a91aa0ac1c8	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	7553d708-22a0-44ea-b907-7a86f2657f4c	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	493a5946-e750-4500-afd1-8f3fdc1d420e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Teva Pharmaceuticals USA, Inc.	06d71a33-5578-4012-b11d-764f45bc1e6a	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5785-61	00904578561	100 BLISTER PACK in 1 CARTON (0904-5785-61) > 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2007-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	Cardinal Health 107, LLC	2024-09-11	HUMAN PRESCRIPTION DRUG LABEL	16
Fluoxetine	Major Pharmaceuticals	2024-09-09	HUMAN PRESCRIPTION DRUG LABEL	16