Fluoxetine

Product NDC: 59651-899
Requested package NDC: 59651-899-26
11-digit product format: 596510899
Labeler code: 59651
Product ID: 59651-899_d0f00a25-1aec-42fd-a301-d3710ae3e1f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078619
Marketing category: ANDA
Marketing start: 2025-07-11
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: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	59651-899	59651-899-26	UNFINISHED	Active or certified unfinished drug listing		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 21:27 UTC · source 2025-12-05	unfinished package	package	59651-899	59651-899-26	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	59651-899	59651-899-26	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`

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
Listing expiration: 2026-12-31

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
d0f00a25-1aec-42fd-a301-d3710ae3e1f3	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
59651-899-00	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100	1
59651-899-05	Fluoxetine	500 in 1 BOTTLE	CAPSULE	500	1
59651-899-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30	1
59651-899-99	Fluoxetine	1000 in 1 BOTTLE	CAPSULE	1000	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-899-00	EA - Each	59651-899	58413be8-25a3-492d-853d-075f9c64006e	1	2026-01-08
59651-899-99	EA - Each	59651-899	d37e3d6f-21ec-4b15-9fab-70fc11c3a290	1	2025-11-13

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
01K63SUP8D	FLUOXETINE	54910-89-3	Fluoxetine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310385	FLUoxetine 20 MG Oral Capsule	PSN	b8666383-462d-4a21-8f49-1d572da386d1	2
310385	fluoxetine 20 MG Oral Capsule	SCD	b8666383-462d-4a21-8f49-1d572da386d1	2
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b8666383-462d-4a21-8f49-1d572da386d1	2
310384	FLUoxetine 10 MG Oral Capsule	PSN	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
310385	FLUoxetine 20 MG Oral Capsule	PSN	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
313989	FLUoxetine 40 MG Oral Capsule	PSN	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
310384	fluoxetine 10 MG Oral Capsule	SCD	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
310385	fluoxetine 20 MG Oral Capsule	SCD	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
313989	fluoxetine 40 MG Oral Capsule	SCD	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-899-26	59651089926	2500 CAPSULE in 1 BAG (59651-899-26)	2500 capsule	11-JUL-25	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	Unit Dose Solutions, Inc.	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	1
Fluoxetine	QPharma Inc \| Northwind Health Company, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluoxetine	REMEDYREPACK INC.	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
Fluoxetine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-07-15	Human Prescription Drug Label	1