famotidine

Generic: famotidine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8558
Product ID 0615-8558_20739b19-9f06-4e88-962e-d812086fdc90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078916
Listing Expiration 2026-12-31
Marketing Start 2016-01-29

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 06158558
Hyphenated Format 0615-8558

Supplemental Identifiers

RxCUI
284245 310273
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 ANDA078916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8558-05)
  • 28 TABLET in 1 BLISTER PACK (0615-8558-28)
  • 30 TABLET in 1 BLISTER PACK (0615-8558-39)
source: ndc

Packages (3)

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "20739b19-9f06-4e88-962e-d812086fdc90", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["59b17677-d805-4d9e-9c64-96385ae47bff"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8558-05)", "package_ndc": "0615-8558-05", "marketing_start_date": "20250116"}, {"sample": false, "description": "28 TABLET in 1 BLISTER PACK (0615-8558-28)", "package_ndc": "0615-8558-28", "marketing_start_date": "20250116"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8558-39)", "package_ndc": "0615-8558-39", "marketing_start_date": "20250116"}], "brand_name": "Famotidine", "product_id": "0615-8558_20739b19-9f06-4e88-962e-d812086fdc90", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0615-8558", "generic_name": "Famotidine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA078916", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20261231"}