Fluoxetine

Product NDC: 67046-210
11-digit product format: 670460210
Labeler code: 67046
Product ID: 67046-210_8609ed02-0b30-4c82-bab1-4d51d92ec224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA075452
Marketing category: ANDA
Marketing start: 2010-07-30
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	67046-210		I	Inactivated by FDA	2026-10-16
excluded package	package	67046-210	67046-210-30	I	Inactivated by FDA	2026-10-16
excluded package	package	67046-210	67046-210-60	I	Inactivated by FDA	2026-10-16

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 2 · 66 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	67046-210-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-210-30	`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	67046-210-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-210-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-210-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-210-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-210-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-210-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-210-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-210-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-210-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-210-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-210-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-210-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67046-210-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67046-210-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67046-210-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67046-210-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67046-210-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67046-210-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67046-210-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67046-210-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67046-210-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67046-210-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-210-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-210-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-210-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-210-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-210-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-210-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-210-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-210-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-210-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-210-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-210-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-210-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-210-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-210-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-210-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-210-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075452-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29
A075452-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29
A075452-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075452-001	AB1
A075452-002	AB1
A075452-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075452-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075452-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075452-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075452-001	AB1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075452-002	AB1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075452-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075452-001	AB1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075452-002	AB1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075452-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075452-001	AB1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075452-002	AB1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075452-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075452-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075452-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075452-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-210-30	2019-10-21	C162847	48780-1	956f9ecf-c22b-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Fluoxetine capsules USP for oral use Initial U.S. Approval: 1987
67046-210-60	2019-10-21	C162847	48780-1	956f9ecf-c22b-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Fluoxetine capsules USP for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-210-30	Fluoxetine	30 in 1 BLISTER PACK	CAPSULE	30		1
67046-210-60	Fluoxetine	60 in 1 BLISTER PACK	CAPSULE	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-210	FLUOXETINE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 2 package rows	20100802_8609ed02-0b30-4c82-bab1-4d51d92ec224.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Teva Pharmaceuticals USA, Inc.	369dbfba-9de4-433c-8680-2ec047b8f8d9	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075452 application number: ANDA075452
Fluoxetine	FLUOXETINE	Proficient Rx LP	5ebf287e-fc95-4a2c-a496-62c7cf6cbf38	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075452 application number: ANDA075452

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
310384	FLUoxetine 10 MG Oral Capsule	PSN	8609ed02-0b30-4c82-bab1-4d51d92ec224	1
310384	fluoxetine 10 MG Oral Capsule	SCD	8609ed02-0b30-4c82-bab1-4d51d92ec224	1
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	8609ed02-0b30-4c82-bab1-4d51d92ec224	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-210-30	67046021030	30 in 1 BLISTER PACK	Historical
67046-210-60	67046021060	60 in 1 BLISTER PACK	Historical