famotidine

Generic: famotidine

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-828
Product ID 58602-828_01351d50-0222-4f6c-93cc-66b2afb98669
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206531
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

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 58602828
Hyphenated Format 58602-828

Supplemental Identifiers

RxCUI
199047
UPC
0358602828196
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 ANDA206531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-828-19) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

58602-828-19 1 BOTTLE in 1 CARTON (58602-828-19) / 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": "01351d50-0222-4f6c-93cc-66b2afb98669", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0358602828196"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047"], "spl_set_id": ["27ecf5c1-202a-44cf-94f9-d7fefa027e1e"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-828-19)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-828-19", "marketing_start_date": "20160426"}], "brand_name": "Famotidine", "product_id": "58602-828_01351d50-0222-4f6c-93cc-66b2afb98669", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "58602-828", "generic_name": "Famotidine", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA206531", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}