famotidine

Generic: famotidine

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-091
Product ID 83008-091_2bfb16cd-192b-4b00-aef4-77d1b927fea9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075718
Marketing Start 2024-09-18
Marketing End 2026-12-31

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008091
Hyphenated Format 83008-091

Supplemental Identifiers

RxCUI
310273
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA075718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (83008-091-30)
source: ndc

Packages (1)

83008-091-30 30 TABLET, FILM COATED in 1 BOTTLE (83008-091-30)

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bfb16cd-192b-4b00-aef4-77d1b927fea9", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["3549386a-533d-4e44-8097-f6bc51ee494a"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (83008-091-30)", "package_ndc": "83008-091-30", "marketing_end_date": "20261231", "marketing_start_date": "20240918"}], "brand_name": "Famotidine", "product_id": "83008-091_2bfb16cd-192b-4b00-aef4-77d1b927fea9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "83008-091", "generic_name": "Famotidine", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA075718", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20240918"}