Fluoxetine

Product NDC: 42543-725
11-digit product format: 425430725
Labeler code: 42543
Product ID: 42543-725_f1764ef9-4324-4e97-a72c-d54bb09245ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Vensun Pharmaceuticals, Inc.
Application: ANDA204597
Marketing category: ANDA
Marketing start: 2015-03-16
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: 2026-12-31
Current FDA listing: Yes

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	Approval date
A204597-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204597-001	AB1
A204597-002	AB1
A204597-003	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	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`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	A204597-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204597-001	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	10 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
b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	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
42543-725-01	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100	9
42543-725-05	Fluoxetine	500 in 1 BOTTLE	CAPSULE	500	9
42543-725-10	Fluoxetine	1000 in 1 BOTTLE	CAPSULE	1000	9
42543-725-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-725-01	EA - Each	42543-725	63d52072-b428-4a7c-9892-820f217f6b33	1	2015-12-02
42543-725-05	EA - Each	42543-725	b4593adf-c3bf-433e-9e6b-eeb797a077bf	1	2015-12-02
42543-725-10	EA - Each	42543-725	2c0f6b01-2bdb-4ab7-b721-c53a98d982ea	1	2015-12-02
42543-725-30	EA - Each	42543-725	0d63f0a2-774e-4691-aea3-4a181a1518dc	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-725	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20171031_b4f37ef1-8f5e-4318-90f1-2d8f8afb669c.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 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	583c5021-2948-7db4-e063-6294a90ae7dc	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	023cef65-c9c2-4d70-af66-198fb1b57714	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine HCL	FLUOXETINE HCL	Direct_rx	48705e4f-c3ee-af78-e063-6394a90ad052	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5386a140-7c5b-5959-e063-6294a90a2ad0	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	a9de93d4-2edc-2838-e053-2995a90a8ed6	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d26f7450-7650-43df-a63b-1fe2472882a9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5020d0d6-969e-b4cd-e063-6294a90af9d2	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ef0fa849-a3a0-45d2-9258-da2d46bee089	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ec608267-9c00-4d5c-a9ed-d89503f93d28	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	e83e2220-d32a-472c-bd9f-b87d0cf8858f	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	d121146e-7439-4169-a421-dab7b882b8aa	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	8b8fe00e-7a2f-486b-9b72-465a494d8939	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	1a07ebe9-3661-4a48-b8af-9b228875166a	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	77d5c10a-0cfc-4b89-942c-0fb5c67ae409	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	2c56a437-f6bf-4ac8-b1d9-fc8a605a97e7	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d23	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	aae4e339-5244-f6f9-e053-2995a90a42ce	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1eec9d-f755-81a2-e053-2a95a90acb3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	cdf3b608-e14c-474b-b80e-01ac5f701866	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	cca9edf9-2454-4bf9-98e8-c531a8f5dc42	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597

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	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	FLUoxetine 20 MG Oral Capsule	PSN	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	FLUoxetine 40 MG Oral Capsule	PSN	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310384	fluoxetine 10 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	fluoxetine 20 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	fluoxetine 40 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310384	FLUoxetine 10 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
310384	fluoxetine 10 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	fluoxetine 20 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	fluoxetine 40 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-725-01	42543072501	100 CAPSULE in 1 BOTTLE (42543-725-01)	100 capsule	2015-03-16	0000-00-00	No	No	Current
42543-725-05	42543072505	500 CAPSULE in 1 BOTTLE (42543-725-05)	500 capsule	2015-03-16	0000-00-00	No	No	Current
42543-725-10	42543072510	1000 CAPSULE in 1 BOTTLE (42543-725-10)	1000 capsule	2015-03-16	0000-00-00	No	No	Current
42543-725-30	42543072530	30 CAPSULE in 1 BOTTLE (42543-725-30)	30 capsule	2015-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	REMEDYREPACK INC.	2020-05-19	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	NuCare Pharmaceuticals,Inc.	2019-03-21	HUMAN PRESCRIPTION DRUG LABEL	2
Fluoxetine	Bryant Ranch Prepack	2019-02-01	Human Prescription Drug Label	3
Fluoxetine	Vensun Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2017-09-18	Human Prescription Drug Label	9