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 72789-453
Product ID 72789-453_324937c3-c52f-bc79-e063-6294a90acc8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215630
Listing Expiration 2026-12-31
Marketing Start 2023-08-23

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 72789453
Hyphenated Format 72789-453

Supplemental Identifiers

RxCUI
284245
UPC
0372789453309
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 ANDA215630 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-453-30)
source: ndc

Packages (1)

72789-453-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-453-30)

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": "324937c3-c52f-bc79-e063-6294a90acc8e", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372789453309"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["a0f38398-4d34-4ecc-8a6a-37732adaaad3"], "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": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-453-30)", "package_ndc": "72789-453-30", "marketing_start_date": "20241114"}], "brand_name": "FAMOTIDINE", "product_id": "72789-453_324937c3-c52f-bc79-e063-6294a90acc8e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72789-453", "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": "ANDA215630", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20261231"}