fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2197
Product ID 63629-2197_02a9b206-9ae1-051e-e063-6294a90afc5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203836
Listing Expiration 2026-12-31
Marketing Start 2016-08-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292197
Hyphenated Format 63629-2197

Supplemental Identifiers

RxCUI
313990
UNII
I9W7N6B1KJ

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 ANDA203836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2197-1)
source: ndc

Packages (1)

63629-2197-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2197-1)

Ingredients (1)

fluoxetine hydrochloride (10 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": "02a9b206-9ae1-051e-e063-6294a90afc5c", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313990"], "spl_set_id": ["fb0608d9-1ae3-43be-8a20-e9f34e955862"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2197-1)", "package_ndc": "63629-2197-1", "marketing_start_date": "20160822"}], "brand_name": "fluoxetine hydrochloride", "product_id": "63629-2197_02a9b206-9ae1-051e-e063-6294a90afc5c", "dosage_form": "TABLET, COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-2197", "generic_name": "fluoxetine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluoxetine hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203836", "marketing_category": "ANDA", "marketing_start_date": "20160822", "listing_expiration_date": "20261231"}