fluoxetine hydrochloride

Product NDC: 63629-8989
11-digit product format: 636298989
Labeler code: 63629
Product ID: 63629-8989_3379faa5-91bf-90cf-e063-6394a90aa096
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluoxetine hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203836
Marketing category: ANDA
Marketing start: 2016-08-22
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203836-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2016-08-19
A203836-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2016-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203836-001	AB
A203836-002	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 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	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`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	A203836-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203836-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203836-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203836-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203836-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203836-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203836-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203836-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203836-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203836-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203836-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203836-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203836-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203836-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203836-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203836-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203836-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203836-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: fluoxetine hydrochloride
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313990	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
80816531-9db3-492b-aebc-4681bf3c1554	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
63629-8989-1	fluoxetine hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, COATED	60		101
63629-8989-2	fluoxetine hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8989-1	EA - Each	63629-8989	d469c919-b96a-4224-a9ed-9b1916962f94	1	2022-04-06
63629-8989-2	EA - Each	63629-8989	93215d49-fdae-4427-9669-1bf138785635	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8989	FLUOXETINE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 2 package rows	20250425_80816531-9db3-492b-aebc-4681bf3c1554.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d4043133-38de-4faa-bb76-8fafa5913844	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a04a5bed-d051-4bb4-ae20-b09b10d5c181	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	fb0608d9-1ae3-43be-8a20-e9f34e955862	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d5a267cb-08bd-4530-a7a8-2bceddd828e5	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	72e391aa-1a46-4589-8550-f83ac9241cf1	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Par Health USA, LLC	53ac797d-8792-4a8c-9708-d1de3d377e8f	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	80816531-9db3-492b-aebc-4681bf3c1554	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-8989
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	da785a8a-d897-494e-9fd2-1d09b32f0190	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836

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
313990	FLUoxetine HCl 10 MG Oral Tablet	PSN	80816531-9db3-492b-aebc-4681bf3c1554	101
313990	fluoxetine 10 MG Oral Tablet	SCD	80816531-9db3-492b-aebc-4681bf3c1554	101
313990	fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral Tablet	SY	80816531-9db3-492b-aebc-4681bf3c1554	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8989-1	63629898901	60 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-1)	2021-12-07	0000-00-00	No	No	Current
63629-8989-2	63629898902	90 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-2)	2021-12-07	0000-00-00	No	No	Current