Fluoxetine

Product NDC: 50111-647
11-digit product format: 501110647
Labeler code: 50111
Product ID: 50111-647_424ed364-e023-472f-b113-673e9342a7f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076001
Marketing category: ANDA
Marketing start: 2002-01-29
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: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076001-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2002-01-29
A076001-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2002-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076001-001	AB1
A076001-002	AB1

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 · 82 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	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076001-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	AB1	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluoxetine
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310384	Internal RxNorm lookup
310385	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
06d71a33-5578-4012-b11d-764f45bc1e6a	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
50111-647-01	Fluoxetine	100 in 1 BOTTLE	CAPSULE	100	32
50111-647-02	Fluoxetine	500 in 1 BOTTLE	CAPSULE	500	32
50111-647-03	Fluoxetine	1000 in 1 BOTTLE	CAPSULE	1000	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-647-01	EA - Each	50111-647	40ccc207-81eb-4e7e-b96b-3f422138de07	1	2012-07-24
50111-647-02	EA - Each	50111-647	40423534-90a5-4566-b0f8-cc46c2acb1fd	1	2012-07-24
50111-647-03	EA - Each	50111-647	85cbdd5f-3842-4215-ae23-e37fd70aaad0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [PLIVA INC.]	17
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [PLIVA INC.]	17
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [PLIVA INC.]	17
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [PLIVA INC.]	17
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [PLIVA INC.]	17
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [PLIVA INC.]	17
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [PLIVA INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [PLIVA INC.]	17
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [PLIVA INC.]	17
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [PLIVA INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [PLIVA INC.]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [PLIVA INC.]	17
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [MAJOR PHARMACEUTICALS]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50111-647	FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	32	Current NDC, Legacy NDC, 3 package rows	20241120_06d71a33-5578-4012-b11d-764f45bc1e6a.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	24926986-7552-4f1a-8366-f035bbd07104	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	1a2a5194-b793-4c62-a177-040dad38526b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	a1b40d46-5233-49d7-9833-762cb6999012	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Northwind Health Company, LLC	4dee4a1a-360c-532e-e063-6394a90a8426	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Legacy Pharmaceutical Packaging, LLC	b07f9eab-44ac-4667-bd46-52d736daa5d6	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	QPharma Inc	b4831735-6731-473a-b4f0-1f4a67aa7120	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	647e17f5-a15a-4e77-922c-24a5db2118bc	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	cece294b-c414-4832-a8a2-22fb66aabda9	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	5631bb72-798a-6efc-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	78994632-74b3-951c-e053-2a91aa0ac1c8	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	7553d708-22a0-44ea-b907-7a86f2657f4c	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	493a5946-e750-4500-afd1-8f3fdc1d420e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Teva Pharmaceuticals USA, Inc.	06d71a33-5578-4012-b11d-764f45bc1e6a	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001 ndc (product): 50111-647

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	7553d708-22a0-44ea-b907-7a86f2657f4c	103
310384	fluoxetine 10 MG Oral Capsule	SCD	7553d708-22a0-44ea-b907-7a86f2657f4c	103
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	7553d708-22a0-44ea-b907-7a86f2657f4c	103
310384	FLUoxetine 10 MG Oral Capsule	PSN	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310385	FLUoxetine 20 MG Oral Capsule	PSN	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310384	fluoxetine 10 MG Oral Capsule	SCD	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310385	fluoxetine 20 MG Oral Capsule	SCD	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	647e17f5-a15a-4e77-922c-24a5db2118bc	33
310384	FLUoxetine 10 MG Oral Capsule	PSN	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310385	FLUoxetine 20 MG Oral Capsule	PSN	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310384	fluoxetine 10 MG Oral Capsule	SCD	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310385	fluoxetine 20 MG Oral Capsule	SCD	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	06d71a33-5578-4012-b11d-764f45bc1e6a	32
310384	FLUoxetine 10 MG Oral Capsule	PSN	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310385	FLUoxetine 20 MG Oral Capsule	PSN	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310384	fluoxetine 10 MG Oral Capsule	SCD	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310385	fluoxetine 20 MG Oral Capsule	SCD	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	b07f9eab-44ac-4667-bd46-52d736daa5d6	16
310384	FLUoxetine 10 MG Oral Capsule	PSN	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310385	FLUoxetine 20 MG Oral Capsule	PSN	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310384	fluoxetine 10 MG Oral Capsule	SCD	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310385	fluoxetine 20 MG Oral Capsule	SCD	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	c1dd46d3-0d09-4f62-81ca-be32409b24c9	15
310384	FLUoxetine 10 MG Oral Capsule	PSN	83df297b-6467-451e-af4d-2c1f996cd009	9
310384	FLUoxetine 10 MG Oral Capsule	PSN	35fee753-acd7-4da2-bd60-973dc6c0b21f	9
310384	fluoxetine 10 MG Oral Capsule	SCD	83df297b-6467-451e-af4d-2c1f996cd009	9
310384	fluoxetine 10 MG Oral Capsule	SCD	35fee753-acd7-4da2-bd60-973dc6c0b21f	9
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	83df297b-6467-451e-af4d-2c1f996cd009	9
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	35fee753-acd7-4da2-bd60-973dc6c0b21f	9
310384	FLUoxetine 10 MG Oral Capsule	PSN	52057058-abdb-44ed-b60d-a718c97fbfda	8
310384	fluoxetine 10 MG Oral Capsule	SCD	52057058-abdb-44ed-b60d-a718c97fbfda	8
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	52057058-abdb-44ed-b60d-a718c97fbfda	8
310384	FLUoxetine 10 MG Oral Capsule	PSN	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310385	FLUoxetine 20 MG Oral Capsule	PSN	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310384	fluoxetine 10 MG Oral Capsule	SCD	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310385	fluoxetine 20 MG Oral Capsule	SCD	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310385	fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule	SY	37bc2c81-ac05-4a7f-aa8f-cc138dd9b895	7
310384	FLUoxetine 10 MG Oral Capsule	PSN	1a2a5194-b793-4c62-a177-040dad38526b	6
310384	FLUoxetine 10 MG Oral Capsule	PSN	e75d342e-5119-4ffe-bb44-edec519df7a7	6
310384	FLUoxetine 10 MG Oral Capsule	PSN	a1b40d46-5233-49d7-9833-762cb6999012	6
310384	fluoxetine 10 MG Oral Capsule	SCD	e75d342e-5119-4ffe-bb44-edec519df7a7	6
310384	fluoxetine 10 MG Oral Capsule	SCD	a1b40d46-5233-49d7-9833-762cb6999012	6
310384	fluoxetine 10 MG Oral Capsule	SCD	1a2a5194-b793-4c62-a177-040dad38526b	6
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	a1b40d46-5233-49d7-9833-762cb6999012	6
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	1a2a5194-b793-4c62-a177-040dad38526b	6
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	e75d342e-5119-4ffe-bb44-edec519df7a7	6
310384	FLUoxetine 10 MG Oral Capsule	PSN	78994632-74b3-951c-e053-2a91aa0ac1c8	4
310384	fluoxetine 10 MG Oral Capsule	SCD	78994632-74b3-951c-e053-2a91aa0ac1c8	4
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	78994632-74b3-951c-e053-2a91aa0ac1c8	4
310384	FLUoxetine 10 MG Oral Capsule	PSN	53655048-40a3-45b2-9336-5616cfab68f0	2
310384	fluoxetine 10 MG Oral Capsule	SCD	53655048-40a3-45b2-9336-5616cfab68f0	2
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	53655048-40a3-45b2-9336-5616cfab68f0	2
310384	FLUoxetine 10 MG Oral Capsule	PSN	4e81573a-ea76-47f8-897e-0e1d98550e46	1
310384	fluoxetine 10 MG Oral Capsule	SCD	4e81573a-ea76-47f8-897e-0e1d98550e46	1
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	4e81573a-ea76-47f8-897e-0e1d98550e46	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50111-647-01	50111064701	100 CAPSULE in 1 BOTTLE (50111-647-01)	100 capsule	2002-01-29	0000-00-00	No	No	Current
50111-647-02	50111064702	500 CAPSULE in 1 BOTTLE (50111-647-02)	500 capsule	2002-01-29	0000-00-00	No	No	Current
50111-647-03	50111064703	1000 CAPSULE in 1 BOTTLE (50111-647-03)	1000 capsule	2002-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	Proficient Rx LP	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	6
Fluoxetine	REMEDYREPACK INC.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	6
Fluoxetine	Legacy Pharmaceutical Packaging, LLC	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	16
Fluoxetine	NCS HealthCare of KY, LLC dba Vangard Labs	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	33
Fluoxetine	Major Pharmaceuticals	2024-09-09	HUMAN PRESCRIPTION DRUG LABEL	16
Fluoxetine	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	Bryant Ranch Prepack	2024-05-17	HUMAN PRESCRIPTION DRUG LABEL	103
Fluoxetine	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	7
Fluoxetine	Teva Pharmaceuticals USA, Inc.	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	32
Fluoxetine	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
Fluoxetine	A-S Medication Solutions	2023-02-09	HUMAN PRESCRIPTION DRUG LABEL	22
Fluoxetine	Clinical Solutions Wholesale, LLC	2022-10-24	HUMAN PRESCRIPTION DRUG LABEL	8
Fluoxetine	A-S Medication Solutions	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	15
Fluoxetine	Lake Erie Medical DBA Quality Care Products LLC	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	3
Fluoxetine	Aidarex Pharmaceuticals LLC	2017-02-23	HUMAN PRESCRIPTION DRUG LABEL	2
Fluoxetine	NCS HealthCare of KY, Inc dba Vangard Labs	2016-09-12	HUMAN PRESCRIPTION DRUG LABEL	27
Fluoxetine	Blenheim Pharmacal, Inc.	2016-02-16	HUMAN PRESCRIPTION DRUG LABEL	7
Fluoxetine	Northwind Pharmaceuticals, LLC	2014-11-13	HUMAN PRESCRIPTION DRUG LABEL	1
FLUOXETINE	STAT Rx USA LLC \| PSS World Medical Inc.	2012-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Sentraflox AM-10	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-17	HUMAN PRESCRIPTION DRUG LABEL	9
Sentroxatine	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	9
Gaboxetine	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	8