famotidine

Generic: famotidine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 40 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-808
Product ID 62135-808_42c9eb63-96d0-3757-e063-6394a90ad58f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075786
Listing Expiration 2026-12-31
Marketing Start 2020-09-23

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 62135808
Hyphenated Format 62135-808

Supplemental Identifiers

RxCUI
284245 310273
UPC
0362135807900 0362135808907
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 ANDA075786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-808-90)
source: ndc

Packages (1)

62135-808-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-808-90)

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": "42c9eb63-96d0-3757-e063-6394a90ad58f", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0362135807900", "0362135808907"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["70714491-1368-4824-98af-03fda52139a9"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-808-90)", "package_ndc": "62135-808-90", "marketing_start_date": "20231208"}], "brand_name": "famotidine", "product_id": "62135-808_42c9eb63-96d0-3757-e063-6394a90ad58f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "62135-808", "generic_name": "famotidine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/1"}], "application_number": "ANDA075786", "marketing_category": "ANDA", "marketing_start_date": "20200923", "listing_expiration_date": "20261231"}