Fluoxetine

Product NDC: 77771-113
11-digit product format: 777710113
Labeler code: 77771
Product ID: 77771-113_3752a193-ad76-4757-8f0a-64d556fe389a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RADHA PHARMACEUTICALS, INC.
Application: ANDA204597
Marketing category: ANDA
Marketing start: 2022-10-24
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: 2027-12-31
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204597-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204597-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204597-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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 ndc (product): 77771-113
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
Fluoxetine	FLUOXETINE HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	23899405-007b-48d9-82a9-a530b8e90784	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597

Additional Listing Data#

Finished product: Yes
Brand name base: Fluoxetine
Listing expiration: 2027-12-31

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
1a07ebe9-3661-4a48-b8af-9b228875166a	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	Strength	SPL version
77771-113-01	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100		3
77771-113-10	Fluoxetine	1000 in 1 BOTTLE	CAPSULE	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
77771-113-01	EA - Each	77771-113	4420e85c-a95a-4885-8594-7a728815c596	1	2022-12-07
77771-113-10	EA - Each	77771-113	757e9def-a36b-485e-94a2-11395e40d611	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77771-113	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [RADHA PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240709_1a07ebe9-3661-4a48-b8af-9b228875166a.zip

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	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310384	FLUoxetine 10 MG Oral Capsule	PSN	1a07ebe9-3661-4a48-b8af-9b228875166a	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	1a07ebe9-3661-4a48-b8af-9b228875166a	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	1a07ebe9-3661-4a48-b8af-9b228875166a	3
310384	fluoxetine 10 MG Oral Capsule	SCD	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310384	fluoxetine 10 MG Oral Capsule	SCD	1a07ebe9-3661-4a48-b8af-9b228875166a	3
310385	fluoxetine 20 MG Oral Capsule	SCD	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310385	fluoxetine 20 MG Oral Capsule	SCD	1a07ebe9-3661-4a48-b8af-9b228875166a	3
313989	fluoxetine 40 MG Oral Capsule	SCD	1a07ebe9-3661-4a48-b8af-9b228875166a	3
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	1a07ebe9-3661-4a48-b8af-9b228875166a	3
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	06582152-d7d3-4e87-8c13-a4416a6ec927	3
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	1a07ebe9-3661-4a48-b8af-9b228875166a	3
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	1a07ebe9-3661-4a48-b8af-9b228875166a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77771-113-01	77771011301	100 CAPSULE in 1 BOTTLE (77771-113-01)	100 capsule	2022-10-24	0000-00-00	No	No	Current
77771-113-10	77771011310	1000 CAPSULE in 1 BOTTLE (77771-113-10)	1000 capsule	2022-10-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	RADHA PHARMACEUTICALS, INC. \| ScieGen Pharmaceuticals, Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	Aphena Pharma Solutions - Tennessee, LLC	2023-04-05	HUMAN PRESCRIPTION DRUG LABEL	3