famotidine

Generic: famotidine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 20 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-299
Product ID 50268-299_2b48da50-80aa-5a6b-e063-6294a90ac167
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075718
Listing Expiration 2026-12-31
Marketing Start 2022-05-25

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 50268299
Hyphenated Format 50268-299

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
  • 50 BLISTER PACK in 1 BOX (50268-299-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-299-11)
source: ndc

Packages (1)

50268-299-15 50 BLISTER PACK in 1 BOX (50268-299-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-299-11)

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": "2b48da50-80aa-5a6b-e063-6294a90ac167", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["dfdca61d-8824-6230-e053-2995a90a209d"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-299-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-299-11)", "package_ndc": "50268-299-15", "marketing_start_date": "20220525"}], "brand_name": "Famotidine", "product_id": "50268-299_2b48da50-80aa-5a6b-e063-6294a90ac167", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "50268-299", "generic_name": "Famotidine", "labeler_name": "AvPAK", "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": "20220525", "listing_expiration_date": "20261231"}