Fluoxetine

Product NDC: 63187-089
11-digit product format: 631870089
Labeler code: 63187
Product ID: 63187-089_0fd31fbf-d316-41d3-8a7a-7a69f291c399
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076990
Marketing category: ANDA
Marketing start: 2005-07-20
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-089		D	Discontinued by firm	2026-08-17
excluded package	package	63187-089	63187-089-30	D	Discontinued by firm	2026-08-17
excluded package	package	63187-089	63187-089-90	D	Discontinued by firm	2026-08-17

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-089-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-089-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-089-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-089-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076990-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL			2004-12-13

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2004-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076990-001	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2004-12-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076990-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076990-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076990-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076990-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076990-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076990-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076990-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076990-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076990-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076990-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076990-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076990-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076990-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A076990-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076990-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076990-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076990-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076990-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076990-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076990-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076990-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076990-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076990-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076990-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-089-30	EA - Each	63187-089	0b5c1da6-21ab-4d81-961c-d554db8f4732	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-089	FLUOXETINE CAPSULE [PROFICIENT RX LP]	4	Legacy NDC	20191121_e3e8aa9d-9daf-4565-85c9-a8d79c46128b.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-089-30	63187008930	30 CAPSULE in 1 BOTTLE (63187-089-30)	30 capsule	2018-11-01	0000-00-00	No	No	Current
63187-089-90	63187008990	90 CAPSULE in 1 BOTTLE (63187-089-90)	90 capsule	2018-11-01	0000-00-00	No	No	Current