fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler endo usa, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-335
Product ID 49884-335_71c75730-de24-4bfe-ad24-c92107cd5b74
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 49884335
Hyphenated Format 49884-335

Supplemental Identifiers

RxCUI
248642 313990
UPC
0349884336103 0349884335106
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 ANDA203836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11)
source: ndc

Packages (2)

49884-335-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01) 49884-335-11 30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11)

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": "71c75730-de24-4bfe-ad24-c92107cd5b74", "openfda": {"upc": ["0349884336103", "0349884335106"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["53ac797d-8792-4a8c-9708-d1de3d377e8f"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)", "package_ndc": "49884-335-01", "marketing_start_date": "20160822"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11)", "package_ndc": "49884-335-11", "marketing_start_date": "20160822"}], "brand_name": "fluoxetine hydrochloride", "product_id": "49884-335_71c75730-de24-4bfe-ad24-c92107cd5b74", "dosage_form": "TABLET, COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "49884-335", "generic_name": "fluoxetine hydrochloride", "labeler_name": "Endo USA, Inc.", "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"}