fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-5306
Product ID 51672-5306_135b375a-b00e-72c3-e063-6394a90af4f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211477
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516725306
Hyphenated Format 51672-5306

Supplemental Identifiers

RxCUI
1190110
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluoxetine hydrochloride (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA211477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6)
source: ndc

Packages (2)

51672-5306-2 500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2) 51672-5306-6 30 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6)

Ingredients (1)

fluoxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

FLUOXETINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "135b375a-b00e-72c3-e063-6394a90af4f3", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["77b6ae48-8e3a-42e6-9b5a-aeed750861e8"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2)", "package_ndc": "51672-5306-2", "marketing_start_date": "20190215"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6)", "package_ndc": "51672-5306-6", "marketing_start_date": "20190215"}], "brand_name": "FLUOXETINE HYDROCHLORIDE", "product_id": "51672-5306_135b375a-b00e-72c3-e063-6394a90af4f3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "51672-5306", "generic_name": "FLUOXETINE HYDROCHLORIDE", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE HYDROCHLORIDE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211477", "marketing_category": "ANDA", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}