famotidine

Generic: famotidine

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

Drug Facts

Product Profile

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

famotidine 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8518
Product ID 68788-8518_5bec0e35-b44e-4712-a29d-021160b52810
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215630
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

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 687888518
Hyphenated Format 68788-8518

Supplemental Identifiers

RxCUI
284245
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 ANDA215630 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8518-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68788-8518-4)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8518-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8518-9)
source: ndc

Packages (4)

68788-8518-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8518-3) 68788-8518-4 14 TABLET, FILM COATED in 1 BOTTLE (68788-8518-4) 68788-8518-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8518-6) 68788-8518-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8518-9)

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": "5bec0e35-b44e-4712-a29d-021160b52810", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["dbf94314-3a34-4f03-80b1-296559b7d6a5"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8518-3)", "package_ndc": "68788-8518-3", "marketing_start_date": "20230901"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68788-8518-4)", "package_ndc": "68788-8518-4", "marketing_start_date": "20230901"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8518-6)", "package_ndc": "68788-8518-6", "marketing_start_date": "20230901"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8518-9)", "package_ndc": "68788-8518-9", "marketing_start_date": "20230901"}], "brand_name": "FAMOTIDINE", "product_id": "68788-8518_5bec0e35-b44e-4712-a29d-021160b52810", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68788-8518", "generic_name": "FAMOTIDINE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FAMOTIDINE", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA215630", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}