famotidine

Generic: famotidine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-859
Product ID 65862-859_e0c726f6-8257-4dba-b2f9-d78d28097bd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206530
Listing Expiration 2026-12-31
Marketing Start 2015-12-22

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 65862859
Hyphenated Format 65862-859

Supplemental Identifiers

RxCUI
284245 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 ANDA206530 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-859-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-859-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-859-30)
  • 10 BLISTER PACK in 1 CARTON (65862-859-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-859-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-859-99)
source: ndc

Packages (5)

65862-859-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-859-01) 65862-859-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-859-05) 65862-859-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-859-30) 65862-859-78 10 BLISTER PACK in 1 CARTON (65862-859-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-859-10) 65862-859-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-859-99)

Ingredients (1)

famotidine (20 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": "e0c726f6-8257-4dba-b2f9-d78d28097bd9", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["b0798337-1a73-415e-8416-613984ce5c65"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-859-01)", "package_ndc": "65862-859-01", "marketing_start_date": "20151222"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-859-05)", "package_ndc": "65862-859-05", "marketing_start_date": "20151222"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-859-30)", "package_ndc": "65862-859-30", "marketing_start_date": "20151222"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-859-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-859-10)", "package_ndc": "65862-859-78", "marketing_start_date": "20151222"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-859-99)", "package_ndc": "65862-859-99", "marketing_start_date": "20151222"}], "brand_name": "Famotidine", "product_id": "65862-859_e0c726f6-8257-4dba-b2f9-d78d28097bd9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "65862-859", "generic_name": "Famotidine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA206530", "marketing_category": "ANDA", "marketing_start_date": "20151222", "listing_expiration_date": "20261231"}