famotidine

Generic: famotidine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-399
Product ID 71610-399_ce00f657-538e-4b73-9126-1cff453be4aa
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 71610399
Hyphenated Format 71610-399

Supplemental Identifiers

RxCUI
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
  • 30 TABLET in 1 BOTTLE (71610-399-30)
  • 90 TABLET in 1 BOTTLE (71610-399-60)
  • 180 TABLET in 1 BOTTLE (71610-399-80)
source: ndc

Packages (3)

71610-399-30 30 TABLET in 1 BOTTLE (71610-399-30) 71610-399-60 90 TABLET in 1 BOTTLE (71610-399-60) 71610-399-80 180 TABLET in 1 BOTTLE (71610-399-80)

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": "ce00f657-538e-4b73-9126-1cff453be4aa", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["b1839d23-20f4-4651-a7d2-8bc3a7583917"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-399-30)", "package_ndc": "71610-399-30", "marketing_start_date": "20200623"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-399-60)", "package_ndc": "71610-399-60", "marketing_start_date": "20200221"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-399-80)", "package_ndc": "71610-399-80", "marketing_start_date": "20200221"}], "brand_name": "Famotidine", "product_id": "71610-399_ce00f657-538e-4b73-9126-1cff453be4aa", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "71610-399", "generic_name": "Famotidine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}