Fluoxetine

Product NDC: 10544-582
11-digit product format: 105440582
Labeler code: 10544
Product ID: 10544-582_1f231e13-c279-45a0-8e5e-c6a21996b69a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA076001
Marketing category: ANDA
Marketing start: 2009-12-22
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-582-90	2020-01-31	C162847	48780-1	9d75b9d1-0eb8-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE CAPSULES USP for oral use Initial U.S. Approval: 1987

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-582-90	Fluoxetine	90 in 1 BOTTLE	CAPSULE	90		7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-582-90	EA - Each	10544-582	baf6c431-b3c2-4af4-af10-e510ce3a05d9	1	2015-05-05

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-582	FLUOXETINE CAPSULE [BLENHEIM PHARMACAL, INC.]	7	Legacy NDC, 1 package rows	20160217_37bc2c81-ac05-4a7f-aa8f-cc138dd9b895.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-582-90	10544058290	90 in 1 BOTTLE	Historical