famotidine

Generic: famotidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-427
Product ID 72789-427_4123bcfe-adfa-2642-e063-6294a90ab06c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215767
Listing Expiration 2026-12-31
Marketing Start 2021-11-04

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 72789427
Hyphenated Format 72789-427

Supplemental Identifiers

RxCUI
284245
UPC
0372789427904
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 ANDA215767 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-427-90)
source: ndc

Packages (1)

72789-427-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-427-90)

Ingredients (1)

famotidine (40 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": "4123bcfe-adfa-2642-e063-6294a90ab06c", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372789427904"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["2f5ec69d-926c-47a2-be47-8fef2e0ff207"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-427-90)", "package_ndc": "72789-427-90", "marketing_start_date": "20240827"}], "brand_name": "Famotidine", "product_id": "72789-427_4123bcfe-adfa-2642-e063-6294a90ab06c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72789-427", "generic_name": "Famotidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA215767", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20261231"}