famotidine

Generic: famotidine

Labeler: akorn
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler akorn
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

famotidine 40 mg/5mL

Manufacturer
Akorn

Identifiers & Regulatory

Product NDC 50383-913
Product ID 50383-913_f448e568-540e-4027-be47-e7a5aa1051d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201995
Listing Expiration 2026-12-31
Marketing Start 2016-03-16

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 50383913
Hyphenated Format 50383-913

Supplemental Identifiers

UPC
0350383913405
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 ANDA201995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (50383-913-40) / 50 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

50383-913-40 1 BOTTLE, GLASS in 1 CARTON (50383-913-40) / 50 mL in 1 BOTTLE, GLASS

Ingredients (1)

famotidine (40 mg/5mL)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f448e568-540e-4027-be47-e7a5aa1051d3", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0350383913405"], "unii": ["5QZO15J2Z8"], "spl_set_id": ["354a5a02-45cb-4ab0-88ee-6635d5a43b01"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Akorn"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (50383-913-40)  / 50 mL in 1 BOTTLE, GLASS", "package_ndc": "50383-913-40", "marketing_start_date": "20160316"}], "brand_name": "Famotidine", "product_id": "50383-913_f448e568-540e-4027-be47-e7a5aa1051d3", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "50383-913", "generic_name": "Famotidine", "labeler_name": "Akorn", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/5mL"}], "application_number": "ANDA201995", "marketing_category": "ANDA", "marketing_start_date": "20160316", "listing_expiration_date": "20261231"}