Fluoxetine

Product NDC: 33261-883
11-digit product format: 332610883
Labeler code: 33261
Product ID: 33261-883_868cf43c-6ce2-49d0-b94f-039efab76e9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076990
Marketing category: ANDA
Marketing start: 2013-09-05
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: 2019-12-31
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	33261-883		I	Inactivated by FDA	2026-08-17
excluded package	package	33261-883	33261-883-30	I	Inactivated by FDA	2026-08-17
excluded package	package	33261-883	33261-883-60	I	Inactivated by FDA	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 2 · 63 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	33261-883-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-883-60	`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	33261-883-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-883-60	`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	33261-883-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-883-60	`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	33261-883-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-883-60	`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	33261-883-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-883-60	`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	33261-883-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-883-60	`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	33261-883-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-883-60	`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	33261-883-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-883-60	`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	33261-883-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-883-60	`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	33261-883-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-883-60	`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	33261-883-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-883-60	`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	33261-883-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-883-60	`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	33261-883-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-883-60	`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	33261-883-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-883-60	`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	33261-883-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-883-60	`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	33261-883-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-883-60	`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	33261-883-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-883-60	`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	33261-883-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-883-60	`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	33261-883-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-883-60	`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	33261-883-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-883-60	`e2bbac7714bc…`	`27bdfed8d636…`

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 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
33261-883-30	2020-01-31	C162847	48780-1	9d75b9d0-9cac-f424-e053-dadaa90a57ce	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
33261-883-60	2020-01-31	C162847	48780-1	9d75b9d0-9cac-f424-e053-dadaa90a57ce	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
33261-883-30	Fluoxetine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		3
33261-883-60	Fluoxetine	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-883-30	EA - Each	33261-883	3279d8e4-b267-43db-bab9-ce02cf52a3df	1	2015-10-02
33261-883-60	EA - Each	33261-883	a8a8071c-bae1-45bd-8e06-e49c929b6d15	1	2015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-883	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 2 package rows	20171229_eb231077-fa47-4469-b3c5-4e13d2365252.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313989	FLUoxetine 40 MG Oral Capsule	PSN	eb231077-fa47-4469-b3c5-4e13d2365252	3
313989	fluoxetine 40 MG Oral Capsule	SCD	eb231077-fa47-4469-b3c5-4e13d2365252	3
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	eb231077-fa47-4469-b3c5-4e13d2365252	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-883-30	33261088330	30 in 1 BOTTLE, PLASTIC	Historical
33261-883-60	33261088360	60 in 1 BOTTLE, PLASTIC	Historical