Fluoxetine

Product NDC: 42543-727
11-digit product format: 425430727
Labeler code: 42543
Product ID: 42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Vensun Pharmaceuticals, Inc.
Application: ANDA204597
Marketing category: ANDA
Marketing start: 2015-03-16
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: 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
A204597-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204597-001	AB1
A204597-002	AB1
A204597-003	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	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`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	A204597-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204597-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204597-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	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	40 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310384	Internal RxNorm lookup
310385	Internal RxNorm lookup
313989	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
b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	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	SPL version
42543-727-01	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100	9
42543-727-05	Fluoxetine	500 in 1 BOTTLE	CAPSULE	500	9
42543-727-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-727-01	EA - Each	42543-727	935dc4b2-30bf-44be-8f30-1f3cf3bf3a40	1	2015-12-02
42543-727-05	EA - Each	42543-727	8c1d0fba-994a-4c2e-afa7-54889674aa27	1	2015-12-02
42543-727-30	EA - Each	42543-727	70eb4a16-0f71-4c5b-9258-15e78ce1ddff	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-727	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20171031_b4f37ef1-8f5e-4318-90f1-2d8f8afb669c.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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	cca9edf9-2454-4bf9-98e8-c531a8f5dc42	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Redpharm Drug	0b3da881-475d-cdee-e063-6394a90aee99	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine HCL	FLUOXETINE HCL	Direct_Rx	0259db51-e1ff-6e7a-e063-6394a90abace	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE	Advanced Rx Pharmacy of Tennessee, LLC	f917063a-226e-0978-e053-6294a90aeb4b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	be4c5102-e0aa-3b89-e053-2a95a90a5d9d	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	e15646e0-a431-4b3d-8d6f-7a3d0dadfcc6	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	3d5d03ff-0d0c-429f-b747-31ff3465d39d	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b1409772-e719-67f5-e053-2995a90ab5b6	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a32f1a0b-a9ee-883a-e053-2a95a90a8c12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a7bea6e9-cf90-a963-e053-2a95a90a1068	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	4915e22f-cecb-4261-8389-9bb417a20e82	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Medsource Pharmaceuticals	1302fc08-d5fa-54b4-e063-6394a90a5275	2024-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a408c325-d2d5-4e88-85ce-96913eb58183	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	c4eeae3d-ae56-4e7e-b07d-02851f12039f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a5d49dee-a7de-44d8-80b5-1aeb89e76938	2023-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	06582152-d7d3-4e87-8c13-a4416a6ec927	2023-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3453755b-3ed6-47a3-b4c7-c64758e7784c	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	57f21f2b-0ec2-49dc-911a-806e5ae880c2	2022-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	a6457d6e-5586-40e9-883d-352ee0527d80	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	0cba1992-3990-42a1-9d9a-77b593bbb02e	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310384	FLUoxetine 10 MG Oral Capsule	PSN	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	FLUoxetine 20 MG Oral Capsule	PSN	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	FLUoxetine 40 MG Oral Capsule	PSN	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310384	fluoxetine 10 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	fluoxetine 20 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	fluoxetine 40 MG Oral Capsule	SCD	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	9
313989	FLUoxetine 40 MG Oral Capsule	PSN	581fee7f-2c89-4815-8af7-9ee4ee4226f8	5
313989	fluoxetine 40 MG Oral Capsule	SCD	581fee7f-2c89-4815-8af7-9ee4ee4226f8	5
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	581fee7f-2c89-4815-8af7-9ee4ee4226f8	5
310384	FLUoxetine 10 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	FLUoxetine 20 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	a6457d6e-5586-40e9-883d-352ee0527d80	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	02283de9-6087-45f7-a9ce-3b082ce860de	3
310384	fluoxetine 10 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	fluoxetine 20 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	fluoxetine 40 MG Oral Capsule	SCD	a6457d6e-5586-40e9-883d-352ee0527d80	3
313989	fluoxetine 40 MG Oral Capsule	SCD	02283de9-6087-45f7-a9ce-3b082ce860de	3
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	a6457d6e-5586-40e9-883d-352ee0527d80	3
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	02283de9-6087-45f7-a9ce-3b082ce860de	3
313989	FLUoxetine 40 MG Oral Capsule	PSN	8fa00971-6d50-2d88-e053-2a95a90aed6a	1
313989	FLUoxetine 40 MG Oral Capsule	PSN	71665258-ad45-4dad-e053-2995a90aedcc	1
313989	fluoxetine 40 MG Oral Capsule	SCD	71665258-ad45-4dad-e053-2995a90aedcc	1
313989	fluoxetine 40 MG Oral Capsule	SCD	8fa00971-6d50-2d88-e053-2a95a90aed6a	1
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	8fa00971-6d50-2d88-e053-2a95a90aed6a	1
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	71665258-ad45-4dad-e053-2995a90aedcc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-727-01	42543072701	100 CAPSULE in 1 BOTTLE (42543-727-01)	100 capsule	2015-03-16	0000-00-00	No	No	Current
42543-727-05	42543072705	500 CAPSULE in 1 BOTTLE (42543-727-05)	500 capsule	2015-03-16	0000-00-00	No	No	Current
42543-727-30	42543072730	30 CAPSULE in 1 BOTTLE (42543-727-30)	30 capsule	2015-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
Fluoxetine	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	REMEDYREPACK INC.	2020-05-18	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	Preferred Pharmaceuticals, Inc.	2019-09-24	HUMAN PRESCRIPTION DRUG LABEL	2
FLUOXETINE	Direct_Rx	2019-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluoxetine	Bryant Ranch Prepack	2019-02-01	Human Prescription Drug Label	3
Fluoxetine	Medsource Pharmaceuticals	2018-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
Fluoxetine	Lake Erie Medical DBA Quality Care Products LLC	2018-07-17	Human Prescription Drug Label	1
Fluoxetine	Vensun Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2017-09-18	Human Prescription Drug Label	9
Fluoxetine	NuCare Pharmaceuticals, Inc.	2017-03-23	HUMAN PRESCRIPTION DRUG LABEL	1