FLUOXETINE

Product NDC: 42571-388
11-digit product format: 425710388
Labeler code: 42571
Product ID: 42571-388_db7da69b-ae48-4161-e053-2995a90a801d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOXETINE
Dosage form: CAPSULE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA216232
Marketing category: ANDA
Marketing start: 2023-01-01
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42571-388		D	Discontinued by firm	2026-10-15
excluded package	package	42571-388	42571-388-01	D	Discontinued by firm	2026-10-15
excluded package	package	42571-388	42571-388-10	D	Discontinued by firm	2026-10-15
excluded package	package	42571-388	42571-388-30	D	Discontinued by firm	2026-10-15

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	Approval date
A216232-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2022-03-29
A216232-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	2022-03-29
A216232-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	2022-03-29

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 · 99 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	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2022-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2022-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2022-03-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2022-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2022-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL		2022-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216232-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216232-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2022-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216232-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2022-03-29	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216232-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216232-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216232-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216232-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216232-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216232-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216232-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216232-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A216232-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A216232-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A216232-003	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216232-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216232-002	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216232-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216232-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216232-002	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216232-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216232-001	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216232-002	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216232-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216232-001	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216232-002	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216232-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216232-001	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216232-002	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216232-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216232-001	AB1	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216232-002	AB1	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216232-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216232-001	AB1	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216232-002	AB1	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216232-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216232-001	AB1	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216232-002	AB1	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216232-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216232-001	AB1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216232-002	AB1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216232-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216232-001	AB1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216232-002	AB1	1	`3a93d1ddd44b…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-388-01	FLUOXETINE	100 in 1 BOTTLE	CAPSULE	100	2
42571-388-10	FLUOXETINE	1000 in 1 BOTTLE	CAPSULE	1000	2
42571-388-30	FLUOXETINE	30 in 1 BOTTLE	CAPSULE	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-388	FLUOXETINE (FLUOXETINE) CAPSULE [MICRO LABS LIMITED]	2	Legacy NDC, 3 package rows	20231012_77b01a37-ba10-4b67-a375-244dfcd94c00.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
310384	FLUoxetine 10 MG Oral Capsule	PSN	77b01a37-ba10-4b67-a375-244dfcd94c00	2
310385	FLUoxetine 20 MG Oral Capsule	PSN	77b01a37-ba10-4b67-a375-244dfcd94c00	2
313989	FLUoxetine 40 MG Oral Capsule	PSN	77b01a37-ba10-4b67-a375-244dfcd94c00	2
310384	fluoxetine 10 MG Oral Capsule	SCD	77b01a37-ba10-4b67-a375-244dfcd94c00	2
310385	fluoxetine 20 MG Oral Capsule	SCD	77b01a37-ba10-4b67-a375-244dfcd94c00	2
313989	fluoxetine 40 MG Oral Capsule	SCD	77b01a37-ba10-4b67-a375-244dfcd94c00	2
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	77b01a37-ba10-4b67-a375-244dfcd94c00	2
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	77b01a37-ba10-4b67-a375-244dfcd94c00	2
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	77b01a37-ba10-4b67-a375-244dfcd94c00	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-388-01	42571038801	100 CAPSULE in 1 BOTTLE (42571-388-01)	100 capsule	2023-01-01	0000-00-00	No	No	Current
42571-388-10	42571038810	1000 CAPSULE in 1 BOTTLE (42571-388-10)	1000 capsule	2023-01-01	0000-00-00	No	No	Current
42571-388-30	42571038830	30 CAPSULE in 1 BOTTLE (42571-388-30)	30 capsule	2023-01-01	0000-00-00	No	No	Current