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

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 Identifiers#

Field, Values table
Field	Values
Unii	I9W7N6B1KJ
Rxcui	310384, 310385

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
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTRAFLOX AM-10 (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
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	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTRAFLOX AM-10 (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	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	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	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTRAFLOX AM-10 (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	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	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	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	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
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 [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [PROFICIENT RX LP]	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 [LEGACY PHARMACEUTICAL PACKAGING]	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
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	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 [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [STAT RX USA LLC]	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 [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [STAT RX USA LLC]	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
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [STAT RX USA 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 [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [STAT RX USA 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

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	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
Fluoxetine	Bryant Ranch Prepack	2024-05-17	HUMAN PRESCRIPTION DRUG LABEL	103
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	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	15
Fluoxetine	Aidarex Pharmaceuticals LLC	2017-02-23	HUMAN PRESCRIPTION DRUG LABEL	2
Fluoxetine	Blenheim Pharmacal, Inc.	2016-02-16	HUMAN PRESCRIPTION DRUG LABEL	7
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

Fluoxetine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#