famotidine

Generic: famotidine

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler glenmark therapeutics inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 10 mg/1

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-112
Product ID 72657-112_5502899d-30bd-4954-8aae-9ab1c034f65f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2027-12-31
Marketing Start 2022-06-01

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 72657112
Hyphenated Format 72657-112

Supplemental Identifiers

RxCUI
199047 310273
UPC
0372657132015 0372657112901 0372657113885
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
  • 1 BOTTLE in 1 CARTON (72657-112-20) / 200 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-112-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

72657-112-20 1 BOTTLE in 1 CARTON (72657-112-20) / 200 TABLET, FILM COATED in 1 BOTTLE 72657-112-90 1 BOTTLE in 1 CARTON (72657-112-90) / 90 TABLET, FILM COATED 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": "5502899d-30bd-4954-8aae-9ab1c034f65f", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372657132015", "0372657112901", "0372657113885"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["95f51f27-d367-4cfd-a15f-7856c9e361fb"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-112-20)  / 200 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-112-20", "marketing_start_date": "20220601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-112-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-112-90", "marketing_start_date": "20220601"}], "brand_name": "Famotidine", "product_id": "72657-112_5502899d-30bd-4954-8aae-9ab1c034f65f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72657-112", "generic_name": "Famotidine", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "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": "20220601", "listing_expiration_date": "20271231"}