famotidine

Generic: famotidine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

famotidine 40 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-228
Product ID 82804-228_702dd4fa-4a78-454d-91c5-493894750f7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217669
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

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 82804228
Hyphenated Format 82804-228

Supplemental Identifiers

RxCUI
284245
UPC
0382804228300
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 ANDA217669 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-228-30)
source: ndc

Packages (1)

82804-228-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-228-30)

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": "702dd4fa-4a78-454d-91c5-493894750f7b", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0382804228300"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245"], "spl_set_id": ["702dd4fa-4a78-454d-91c5-493894750f7b"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-228-30)", "package_ndc": "82804-228-30", "marketing_start_date": "20250703"}], "brand_name": "Famotidine", "product_id": "82804-228_702dd4fa-4a78-454d-91c5-493894750f7b", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "82804-228", "generic_name": "Famotidine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA217669", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20261231"}