famotidine

Generic: famotidine

Labeler: geri-care pharmaceutical corp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler geri-care pharmaceutical corp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Geri-Care Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 57896-319
Product ID 57896-319_288ab319-e163-0a6b-e063-6394a90a9205
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 57896319
Hyphenated Format 57896-319

Supplemental Identifiers

RxCUI
310273
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 ANDA215822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57896-319-01) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

57896-319-01 1 BOTTLE in 1 CARTON (57896-319-01) / 100 TABLET, FILM COATED in 1 BOTTLE

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": "288ab319-e163-0a6b-e063-6394a90a9205", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["288a8f87-e84a-a77a-e063-6294a90a86db"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Geri-Care Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57896-319-01)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57896-319-01", "marketing_start_date": "20240401"}], "brand_name": "Famotidine", "product_id": "57896-319_288ab319-e163-0a6b-e063-6394a90a9205", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "57896-319", "generic_name": "Famotidine", "labeler_name": "Geri-Care Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA215822", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}