famotidine

Generic: famotidine

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-400
Product ID 69367-400_497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217669
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

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 69367400
Hyphenated Format 69367-400

Supplemental Identifiers

RxCUI
284245 310273
UPC
0369367400107
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA217669 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-400-10)
source: ndc

Packages (1)

69367-400-10 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-400-10)

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": "497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0369367400107"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["c0e15f57-ab20-4030-b1d1-6aff33be7d76"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-400-10)", "package_ndc": "69367-400-10", "marketing_start_date": "20240909"}], "brand_name": "Famotidine", "product_id": "69367-400_497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "69367-400", "generic_name": "Famotidine", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA217669", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20261231"}