famotidine

Generic: famotidine

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler bi-mart
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 10 mg/1

Manufacturer
Bi-Mart

Identifiers & Regulatory

Product NDC 37835-161
Product ID 37835-161_36d0b020-635f-6e30-e063-6394a90a0053
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

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 37835161
Hyphenated Format 37835-161

Supplemental Identifiers

RxCUI
199047
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 ANDA215822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (37835-161-50)
source: ndc

Packages (1)

37835-161-50 50 TABLET in 1 BOTTLE (37835-161-50)

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": "36d0b020-635f-6e30-e063-6394a90a0053", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047"], "spl_set_id": ["9974aa5e-e03f-4459-934a-ece27a830746"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bi-Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (37835-161-50)", "package_ndc": "37835-161-50", "marketing_start_date": "20250401"}], "brand_name": "Famotidine", "product_id": "37835-161_36d0b020-635f-6e30-e063-6394a90a0053", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "37835-161", "generic_name": "Famotidine", "labeler_name": "Bi-Mart", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA215822", "marketing_category": "ANDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}