famotidine

Generic: famotidine

Labeler: chain drug marketing association, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler chain drug marketing association, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION, INC.

Identifiers & Regulatory

Product NDC 83324-008
Product ID 83324-008_14a35301-b682-06ca-e063-6394a90a7bc6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215766
Listing Expiration 2026-12-31
Marketing Start 2024-03-06

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 83324008
Hyphenated Format 83324-008

Supplemental Identifiers

RxCUI
199047 310273
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 ANDA215766 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (83324-008-50) / 50 TABLET, FILM COATED in 1 CONTAINER
source: ndc

Packages (1)

83324-008-50 1 CONTAINER in 1 CARTON (83324-008-50) / 50 TABLET, FILM COATED in 1 CONTAINER

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": "14a35301-b682-06ca-e063-6394a90a7bc6", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (83324-008-50)  / 50 TABLET, FILM COATED in 1 CONTAINER", "package_ndc": "83324-008-50", "marketing_start_date": "20240306"}], "brand_name": "famotidine", "product_id": "83324-008_14a35301-b682-06ca-e063-6394a90a7bc6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "83324-008", "generic_name": "famotidine", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA215766", "marketing_category": "ANDA", "marketing_start_date": "20240306", "listing_expiration_date": "20261231"}