fluoxetine hydrochloride

Product NDC: 51655-101
11-digit product format: 516550101
Labeler code: 51655
Product ID: 51655-101_1371cbfe-0382-47cc-b787-927b6c328df0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluoxetine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA076001
Marketing category: ANDA
Marketing start: 2014-11-03
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: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-101-52	2026-01-06	C162847	48780-1	9d75b9d0-667c-f424-e053-dadaa90a57ce	26769008-c635-4b16-b8db-d2a3c9f1cc2b
51655-101-52	2020-01-31	C162847	48780-1	9d75b9d0-667c-f424-e053-dadaa90a57ce	26769008-c635-4b16-b8db-d2a3c9f1cc2b

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-101	FLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20141113_26769008-c635-4b16-b8db-d2a3c9f1cc2b.zip