Fluoxetine

Product NDC: 21695-054
11-digit product format: 216950054
Labeler code: 21695
Product ID: 21695-054_e6c2595a-1470-4cf4-93ea-0fedf917cf85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076990
Marketing category: ANDA
Marketing start: 2005-07-20
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 40 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
21695-054-07	2019-09-24	C162847	48780-1	934fe258-495c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine. Initial U.S. Approval: 1987
21695-054-30	2019-09-24	C162847	48780-1	934fe258-495c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine. Initial U.S. Approval: 1987
21695-054-60	2019-09-24	C162847	48780-1	934fe258-495c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine. Initial U.S. Approval: 1987
21695-054-90	2019-09-24	C162847	48780-1	934fe258-495c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine. Initial U.S. Approval: 1987

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-054-07	Fluoxetine	7 in 1 BOTTLE	CAPSULE	7	1
21695-054-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30	1
21695-054-60	Fluoxetine	60 in 1 BOTTLE	CAPSULE	60	1
21695-054-90	Fluoxetine	90 in 1 BOTTLE	CAPSULE	90	1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-054-07	EA - Each	21695-054	1a2107f4-a883-4ebc-94c6-dff4e5c14b63	1	2012-07-24
21695-054-30	EA - Each	21695-054	792cfc11-e315-49d0-ab29-4cd6fac09777	1	2012-07-24
21695-054-60	EA - Each	21695-054	ce2fbd39-5748-472f-ba8a-9da4a7fc5a48	1	2012-07-24
21695-054-90	EA - Each	21695-054	c2fa6f92-dbfd-48c6-8bb9-48efa11c0bc4	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-054	FLUOXETINE CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20101201_e6c2595a-1470-4cf4-93ea-0fedf917cf85.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
313989	FLUoxetine 40 MG Oral Capsule	PSN	e6c2595a-1470-4cf4-93ea-0fedf917cf85	1
313989	fluoxetine 40 MG Oral Capsule	SCD	e6c2595a-1470-4cf4-93ea-0fedf917cf85	1
313989	fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule	SY	e6c2595a-1470-4cf4-93ea-0fedf917cf85	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-054-07	21695005407	7 in 1 BOTTLE	Historical
21695-054-30	21695005430	30 in 1 BOTTLE	Historical
21695-054-60	21695005460	60 in 1 BOTTLE	Historical
21695-054-90	21695005490	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine - Rebel Distributors Corp	Rebel Distributors Corp	2010-09-28	HUMAN PRESCRIPTION DRUG LABEL	1