Fluoxetine

Product NDC: 72789-557
Requested package NDC: 72789-557-30
11-digit product format: 727890557
Labeler code: 72789
Product ID: 72789-557_5100b624-aa6d-8eb4-e063-6294a90a9af5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA206993
Marketing category: ANDA
Marketing start: 2021-09-08
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 10 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

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

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
A206993-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23
A206993-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23
A206993-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206993-001	AB1
A206993-002	AB1
A206993-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206993-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206993-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206993-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206993-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206993-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206993-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206993-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-001	AB1	1	`301d65b070ca…`

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	10 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
310384	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
51b8e791-4e9a-4014-b4d8-68fd51ca889f	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
72789-557-30	Fluoxetine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		6
72789-557-90	Fluoxetine	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-557-90	EA - Each	72789-557	5156a982-5109-4553-9710-40265aeb6982	1	2026-05-22

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	PD-Rx Pharmaceuticals, Inc.	51b8e791-4e9a-4014-b4d8-68fd51ca889f	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993 ndc (package): 72789-557-30 ndc (product): 72789-557 ndc11 (package): 72789055730
Fluoxetine	FLUOXETINE	Coupler LLC	50117d4f-0777-54d3-e063-6394a90a857c	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993
Fluoxetine	FLUOXETINE	Cadila Pharmaceuticals Limited	9651816f-58f5-4bf8-8183-6f3d84d36b5c	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993
Fluoxetine	FLUOXETINE	Modavar Pharmaceuticals LLC	05b0781b-50e2-4311-bde0-430b96e2ef8e	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993

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	51b8e791-4e9a-4014-b4d8-68fd51ca889f	6
310384	fluoxetine 10 MG Oral Capsule	SCD	51b8e791-4e9a-4014-b4d8-68fd51ca889f	6
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	51b8e791-4e9a-4014-b4d8-68fd51ca889f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-557-30	72789055730	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-557-30)	30 capsule	2026-05-04	No	No	Current