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 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-331
Product ID 72789-331_41c182b7-7b97-e23a-e063-6394a90ab53f
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 72789331
Hyphenated Format 72789-331

Supplemental Identifiers

RxCUI
310273
UPC
0372789331201
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
  • 20 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-02)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-90)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-93)
source: ndc

Packages (6)

72789-331-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-02) 72789-331-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-20) 72789-331-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-30) 72789-331-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-60) 72789-331-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-90) 72789-331-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-93)

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": "41c182b7-7b97-e23a-e063-6394a90ab53f", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372789331201"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["002875d2-8c30-2d2e-e063-6294a90ae01e"], "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": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-02)", "package_ndc": "72789-331-02", "marketing_start_date": "20240730"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-20)", "package_ndc": "72789-331-20", "marketing_start_date": "20230710"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-30)", "package_ndc": "72789-331-30", "marketing_start_date": "20230801"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-60)", "package_ndc": "72789-331-60", "marketing_start_date": "20230728"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-90)", "package_ndc": "72789-331-90", "marketing_start_date": "20230717"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-331-93)", "package_ndc": "72789-331-93", "marketing_start_date": "20230807"}], "brand_name": "Famotidine", "product_id": "72789-331_41c182b7-7b97-e23a-e063-6394a90ab53f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72789-331", "generic_name": "Famotidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA215767", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20261231"}