famotidine

Generic: famotidine

Labeler: magno-humphries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler magno-humphries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Magno-Humphries, Inc.

Identifiers & Regulatory

Product NDC 54257-802
Product ID 54257-802_54c5dd3f-7261-47e2-adfc-23ef9955eb39
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206531
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

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 54257802
Hyphenated Format 54257-802

Supplemental Identifiers

RxCUI
310273
UPC
0043292564720
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 ANDA206531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02)
source: ndc

Packages (1)

54257-802-02 100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02)

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": "54c5dd3f-7261-47e2-adfc-23ef9955eb39", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0043292564720"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Magno-Humphries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02)", "package_ndc": "54257-802-02", "marketing_start_date": "20160426"}], "brand_name": "Famotidine", "product_id": "54257-802_54c5dd3f-7261-47e2-adfc-23ef9955eb39", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "54257-802", "generic_name": "Famotidine", "labeler_name": "Magno-Humphries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA206531", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}