famotidine

Generic: famotidine

Labeler: twin med llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler twin med llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 10 mg/1

Manufacturer
TWIN MED LLC

Identifiers & Regulatory

Product NDC 55681-341
Product ID 55681-341_f7f1bb4e-df0e-8a7b-e053-6294a90a9c47
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2026-12-31
Marketing Start 2022-01-28

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 55681341
Hyphenated Format 55681-341

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 300 TABLET, FILM COATED in 1 BOTTLE (55681-341-03)
source: ndc

Packages (1)

55681-341-03 300 TABLET, FILM COATED in 1 BOTTLE (55681-341-03)

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": "f7f1bb4e-df0e-8a7b-e053-6294a90a9c47", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["f7f1bb4e-df0d-8a7b-e053-6294a90a9c47"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["TWIN MED LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (55681-341-03)", "package_ndc": "55681-341-03", "marketing_start_date": "20220907"}], "brand_name": "Famotidine", "product_id": "55681-341_f7f1bb4e-df0e-8a7b-e053-6294a90a9c47", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "55681-341", "generic_name": "Famotidine", "labeler_name": "TWIN MED LLC", "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": "20220128", "listing_expiration_date": "20261231"}