Fluoxetine

Product NDC: 49884-468
11-digit product format: 498840468
Labeler code: 49884
Product ID: 49884-468_ea0f9b50-185b-4a12-824e-3a7628aa0906
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA209419
Marketing category: ANDA
Marketing start: 2017-11-16
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209419-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB		2017-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209419-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209419-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2017-11-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209419-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209419-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209419-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209419-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209419-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209419-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209419-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209419-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209419-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209419-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209419-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209419-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209419-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209419-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209419-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209419-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209419-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209419-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209419-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209419-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209419-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209419-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209419-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209419-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209419-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209419-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209419-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209419-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209419-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209419-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209419-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209419-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209419-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209419-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209419-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209419-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209419-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209419-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209419-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209419-001	AB	1	`cb3db0bc1861…`

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
6fff3732-efc3-4cbd-a8fa-cde3181f03e6	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e7177a8f-11de-ee90-ca22-068e6ef54cf5	Product name	4	20230104
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-468-11	Fluoxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-468-11	EA - Each	49884-468	af996b64-f370-4e66-950b-dc041fd5d358	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-468	FLUOXETINE TABLET, FILM COATED [ENDO USA, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20250112_6fff3732-efc3-4cbd-a8fa-cde3181f03e6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Par Health USA, LLC	6fff3732-efc3-4cbd-a8fa-cde3181f03e6	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209419 application number: ANDA209419 ndc (product): 49884-468
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	10293946-5a06-4c21-9f78-941be360b09b	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209419 application number: ANDA209419
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	dced86a0-fc08-465c-897c-f8899e6206d5	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209419 application number: ANDA209419

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	10293946-5a06-4c21-9f78-941be360b09b	104
1190110	fluoxetine 60 MG Oral Tablet	SCD	10293946-5a06-4c21-9f78-941be360b09b	104
1190110	fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet	SY	10293946-5a06-4c21-9f78-941be360b09b	104
1190110	FLUoxetine HCl 60 MG Oral Tablet	PSN	dced86a0-fc08-465c-897c-f8899e6206d5	103
1190110	fluoxetine 60 MG Oral Tablet	SCD	dced86a0-fc08-465c-897c-f8899e6206d5	103
1190110	fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet	SY	dced86a0-fc08-465c-897c-f8899e6206d5	103
1190110	FLUoxetine HCl 60 MG Oral Tablet	PSN	6fff3732-efc3-4cbd-a8fa-cde3181f03e6	9
1190110	fluoxetine 60 MG Oral Tablet	SCD	6fff3732-efc3-4cbd-a8fa-cde3181f03e6	9
1190110	fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet	SY	6fff3732-efc3-4cbd-a8fa-cde3181f03e6	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-468-11	49884046811	30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11)	2017-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	Par Health USA, LLC	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	11
Fluoxetine	Bryant Ranch Prepack	2024-05-14	HUMAN PRESCRIPTION DRUG LABEL	104
Fluoxetine	Bryant Ranch Prepack	2024-04-11	HUMAN PRESCRIPTION DRUG LABEL	103