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 10 mg/1

Manufacturer
GERI-CARE PHARMACEUTICAL CORP

Identifiers & Regulatory

Product NDC 57896-317
Product ID 57896-317_2875fd94-dabd-960e-e063-6394a90a623c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 57896317
Hyphenated Format 57896-317

Supplemental Identifiers

RxCUI
199047
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
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57896-317-03) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (57896-317-06) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

57896-317-03 1 BOTTLE in 1 CARTON (57896-317-03) / 30 TABLET, FILM COATED in 1 BOTTLE 57896-317-06 1 BOTTLE in 1 CARTON (57896-317-06) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

famotidine (10 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": "2875fd94-dabd-960e-e063-6394a90a623c", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047"], "spl_set_id": ["287601b0-04ba-9611-e063-6394a90a9180"], "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 (57896-317-03)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57896-317-03", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (57896-317-06)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57896-317-06", "marketing_start_date": "20240301"}], "brand_name": "Famotidine", "product_id": "57896-317_2875fd94-dabd-960e-e063-6394a90a623c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "57896-317", "generic_name": "Famotidine", "labeler_name": "GERI-CARE PHARMACEUTICAL CORP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA215822", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}