famotidine

Generic: famotidine

Labeler: ascent pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 10 mg/1

Manufacturer
Ascent Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43602-511
Product ID 43602-511_a2adad08-283e-4617-b3db-1eade7f5b296
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216030
Listing Expiration 2026-12-31
Marketing Start 2021-11-03

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 43602511
Hyphenated Format 43602-511

Supplemental Identifiers

RxCUI
199047 310273
UPC
0343602511032 0343602602037
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 ANDA216030 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43602-511-03) / 300 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43602-511-30) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (2)

43602-511-03 1 BOTTLE in 1 CARTON (43602-511-03) / 300 TABLET in 1 BOTTLE 43602-511-30 1 BOTTLE in 1 CARTON (43602-511-30) / 30 TABLET in 1 BOTTLE

Ingredients (1)

famotidine (10 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": "a2adad08-283e-4617-b3db-1eade7f5b296", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0343602511032", "0343602602037"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["b481dd30-7d64-43ec-85d4-2289db62cad7"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Ascent Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43602-511-03)  / 300 TABLET in 1 BOTTLE", "package_ndc": "43602-511-03", "marketing_start_date": "20211103"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43602-511-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "43602-511-30", "marketing_start_date": "20211103"}], "brand_name": "FAMOTIDINE", "product_id": "43602-511_a2adad08-283e-4617-b3db-1eade7f5b296", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "43602-511", "generic_name": "Famotidine", "labeler_name": "Ascent Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FAMOTIDINE", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA216030", "marketing_category": "ANDA", "marketing_start_date": "20211103", "listing_expiration_date": "20261231"}