famotidine

Generic: famotidine

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler northstar rx llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

famotidine 40 mg/5mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-171
Product ID 72603-171_04aaf2b3-3610-056f-e063-6394a90a91df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215043
Listing Expiration 2026-12-31
Marketing Start 2023-09-07

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 72603171
Hyphenated Format 72603-171

Supplemental Identifiers

RxCUI
310274
UPC
0372603171013
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 ANDA215043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (72603-171-01)
source: ndc

Packages (1)

72603-171-01 50 mL in 1 BOTTLE (72603-171-01)

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": "04aaf2b3-3610-056f-e063-6394a90a91df", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0372603171013"], "unii": ["5QZO15J2Z8"], "rxcui": ["310274"], "spl_set_id": ["04aaf296-f136-29d7-e063-6294a90affe1"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (72603-171-01)", "package_ndc": "72603-171-01", "marketing_start_date": "20230907"}], "brand_name": "Famotidine", "product_id": "72603-171_04aaf2b3-3610-056f-e063-6394a90a91df", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "72603-171", "generic_name": "Famotidine", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/5mL"}], "application_number": "ANDA215043", "marketing_category": "ANDA", "marketing_start_date": "20230907", "listing_expiration_date": "20261231"}