Fluoxetine

Product NDC: 50090-6066
Requested package NDC: 50090-6066-0
11-digit product format: 500906066
Labeler code: 50090
Product ID: 50090-6066_9853c9a4-1176-4ff0-b03e-19f2924fd093
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078619
Marketing category: ANDA
Marketing start: 2008-01-31
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-6066	50090-6066-0	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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
50090-6066-0	2024-01-30	C162847	48780-1	1030e365-4013-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, 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
50090-6066-0	Fluoxetine	1 in 1 CARTON	CAPSULE	1		1
50090-6066-0	Fluoxetine	32 in 1 BLISTER PACK	CAPSULE	32		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6066	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 2 package rows	20220919_f54fa907-b1f5-4c11-9e1e-471998c07df2.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
310384	FLUoxetine 10 MG Oral Capsule	PSN	f54fa907-b1f5-4c11-9e1e-471998c07df2	1
310384	fluoxetine 10 MG Oral Capsule	SCD	f54fa907-b1f5-4c11-9e1e-471998c07df2	1
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	f54fa907-b1f5-4c11-9e1e-471998c07df2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6066-0	50090606600	1 BLISTER PACK in 1 CARTON (50090-6066-0) > 32 CAPSULE in 1 BLISTER PACK	1 blister pack	2022-09-09	0000-00-00	No	No	Current