Fluoxetine

Product NDC: 84386-106
Requested package NDC: 84386-106-39
11-digit product format: 843860106
Labeler code: 84386
Product ID: 84386-106_bed68a4a-234d-4871-b61a-90bc7e10f61e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA213265
Marketing category: ANDA
Marketing start: 2026-01-15
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	84386-106	84386-106-39	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213265-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213265-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2020-06-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213265-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	RS	2020-06-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213265-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213265-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213265-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213265-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213265-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213265-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213265-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213265-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213265-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213265-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213265-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213265-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213265-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213265-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213265-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213265-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213265-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213265-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213265-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213265-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213265-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213265-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213265-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213265-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213265-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213265-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213265-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213265-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213265-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213265-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213265-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213265-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213265-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213265-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213265-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213265-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213265-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213265-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213265-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Fluoxetine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	60 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
1190110	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
a9ed97dd-8041-4a02-889c-dcb8b2805f36	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
84386-106-30	Fluoxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	a9ed97dd-8041-4a02-889c-dcb8b2805f36	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213265 application number: ANDA213265 ndc (product): 84386-106
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	7a631271-9597-42a4-a924-1d06ecaba8c8	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213265 application number: ANDA213265
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	5336ce59-7a6c-4db9-8512-299cc5e599c0	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213265 application number: ANDA213265

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
1190110	FLUoxetine HCl 60 MG Oral Tablet	PSN	a9ed97dd-8041-4a02-889c-dcb8b2805f36	1
1190110	fluoxetine 60 MG Oral Tablet	SCD	a9ed97dd-8041-4a02-889c-dcb8b2805f36	1
1190110	fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet	SY	a9ed97dd-8041-4a02-889c-dcb8b2805f36	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
84386-106-39	84386010639	3000 TABLET, FILM COATED in 1 BAG (84386-106-39)	15-JAN-26	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-07-15	Human Prescription Drug Label	2