famotidine

Generic: famotidine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-543
Product ID 72189-543_138d9ed1-2f90-d19d-e063-6394a90a695d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075718
Listing Expiration 2026-12-31
Marketing Start 2024-03-13

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 72189543
Hyphenated Format 72189-543

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
  • 20 TABLET, FILM COATED in 1 BOTTLE (72189-543-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-543-30)
source: ndc

Packages (2)

72189-543-20 20 TABLET, FILM COATED in 1 BOTTLE (72189-543-20) 72189-543-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-543-30)

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": "138d9ed1-2f90-d19d-e063-6394a90a695d", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["138d9ed1-2f8f-d19d-e063-6394a90a695d"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (72189-543-20)", "package_ndc": "72189-543-20", "marketing_start_date": "20240313"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-543-30)", "package_ndc": "72189-543-30", "marketing_start_date": "20240313"}], "brand_name": "Famotidine", "product_id": "72189-543_138d9ed1-2f90-d19d-e063-6394a90a695d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72189-543", "generic_name": "Famotidine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA075718", "marketing_category": "ANDA", "marketing_start_date": "20240313", "listing_expiration_date": "20261231"}