famotidine

Generic: famotidine

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler xlcare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 40 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-215
Product ID 72865-215_b37fe9a5-6465-4518-823d-5d369a4c7793
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215689
Listing Expiration 2026-12-31
Marketing Start 2021-10-15

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 72865215
Hyphenated Format 72865-215

Supplemental Identifiers

RxCUI
284245 310273
UPC
0372865214015 0372865214053 0372865215180 0372865215302 0372865214305 0372865215012 0372865215050 0372865214183
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 ANDA215689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72865-215-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72865-215-05)
  • 180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72865-215-30)
source: ndc

Packages (4)

72865-215-01 100 TABLET, FILM COATED in 1 BOTTLE (72865-215-01) 72865-215-05 500 TABLET, FILM COATED in 1 BOTTLE (72865-215-05) 72865-215-18 180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18) 72865-215-30 30 TABLET, FILM COATED in 1 BOTTLE (72865-215-30)

Ingredients (1)

famotidine (40 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": "b37fe9a5-6465-4518-823d-5d369a4c7793", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372865214015", "0372865214053", "0372865215180", "0372865215302", "0372865214305", "0372865215012", "0372865215050", "0372865214183"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["7b550cf9-221f-4f28-ba99-414ad7d5612f"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72865-215-01)", "package_ndc": "72865-215-01", "marketing_start_date": "20211015"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72865-215-05)", "package_ndc": "72865-215-05", "marketing_start_date": "20211015"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18)", "package_ndc": "72865-215-18", "marketing_start_date": "20211015"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72865-215-30)", "package_ndc": "72865-215-30", "marketing_start_date": "20211015"}], "brand_name": "FAMOTIDINE", "product_id": "72865-215_b37fe9a5-6465-4518-823d-5d369a4c7793", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72865-215", "generic_name": "Famotidine", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FAMOTIDINE", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA215689", "marketing_category": "ANDA", "marketing_start_date": "20211015", "listing_expiration_date": "20261231"}