famotidine

Generic: famotidine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 40 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-624
Product ID 64980-624_3f43a0a4-1606-4d45-95c0-46b73e504010
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218181
Listing Expiration 2026-12-31
Marketing Start 2024-05-06

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 64980624
Hyphenated Format 64980-624

Supplemental Identifiers

RxCUI
284245 310273
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 ANDA218181 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (64980-624-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (64980-624-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (64980-624-50)
source: ndc

Packages (3)

64980-624-01 100 TABLET, FILM COATED in 1 BOTTLE (64980-624-01) 64980-624-10 1000 TABLET, FILM COATED in 1 BOTTLE (64980-624-10) 64980-624-50 500 TABLET, FILM COATED in 1 BOTTLE (64980-624-50)

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": "3f43a0a4-1606-4d45-95c0-46b73e504010", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["15b87f7f-1abf-4d8a-bdbe-03bea0021a68"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (64980-624-01)", "package_ndc": "64980-624-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (64980-624-10)", "package_ndc": "64980-624-10", "marketing_start_date": "20240506"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64980-624-50)", "package_ndc": "64980-624-50", "marketing_start_date": "20240506"}], "brand_name": "Famotidine", "product_id": "64980-624_3f43a0a4-1606-4d45-95c0-46b73e504010", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "64980-624", "generic_name": "Famotidine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA218181", "marketing_category": "ANDA", "marketing_start_date": "20240506", "listing_expiration_date": "20261231"}