famotidine

Generic: famotidine

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

Drug Facts

Product Profile

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

famotidine 40 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4197
Product ID 68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075805
Listing Expiration 2026-12-31
Marketing Start 2001-04-16

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 680714197
Hyphenated Format 68071-4197

Supplemental Identifiers

RxCUI
284245
UPC
0368071419733
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 ANDA075805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-4197-3)
  • 60 TABLET in 1 BOTTLE (68071-4197-6)
  • 90 TABLET in 1 BOTTLE (68071-4197-9)
source: ndc

Packages (3)

68071-4197-3 30 TABLET in 1 BOTTLE (68071-4197-3) 68071-4197-6 60 TABLET in 1 BOTTLE (68071-4197-6) 68071-4197-9 90 TABLET in 1 BOTTLE (68071-4197-9)

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": "1a3b98e7-ec70-569d-e063-6394a90a4470", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0368071419733"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["60cd0973-f74e-2b70-e053-2a91aa0a4361"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-4197-3)", "package_ndc": "68071-4197-3", "marketing_start_date": "20171220"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-4197-6)", "package_ndc": "68071-4197-6", "marketing_start_date": "20171220"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-4197-9)", "package_ndc": "68071-4197-9", "marketing_start_date": "20171220"}], "brand_name": "Famotidine", "product_id": "68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68071-4197", "generic_name": "Famotidine", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA075805", "marketing_category": "ANDA", "marketing_start_date": "20010416", "listing_expiration_date": "20261231"}