famotidine

Generic: famotidine

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

Drug Facts

Product Profile

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

famotidine 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4084
Product ID 70518-4084_47676b70-4de2-8f01-e063-6394a90a4a18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215630
Listing Expiration 2027-12-31
Marketing Start 2024-05-17

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 705184084
Hyphenated Format 70518-4084

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
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-2)
source: ndc

Packages (2)

70518-4084-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-1) 70518-4084-2 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-2)

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": "47676b70-4de2-8f01-e063-6394a90a4a18", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["9c5dce17-1865-4aa6-89f6-24dd55b5f06c"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-1)", "package_ndc": "70518-4084-1", "marketing_start_date": "20250529"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-2)", "package_ndc": "70518-4084-2", "marketing_start_date": "20251012"}], "brand_name": "FAMOTIDINE", "product_id": "70518-4084_47676b70-4de2-8f01-e063-6394a90a4a18", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "70518-4084", "generic_name": "FAMOTIDINE", "labeler_name": "REMEDYREPACK 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": "20240517", "listing_expiration_date": "20271231"}