famotidine

Generic: famotidine

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler upsher-smith laboratories, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

famotidine 40 mg/5mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6045
Product ID 0832-6045_266982a6-6b63-69ae-e063-6394a90af64a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217655
Listing Expiration 2026-12-31
Marketing Start 2023-06-16

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 08326045
Hyphenated Format 0832-6045

Supplemental Identifiers

RxCUI
310274
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 ANDA217655 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (0832-6045-10)
  • 150 mL in 1 BOTTLE (0832-6045-15)
  • 50 mL in 1 BOTTLE (0832-6045-50)
source: ndc

Packages (3)

0832-6045-10 100 mL in 1 BOTTLE (0832-6045-10) 0832-6045-15 150 mL in 1 BOTTLE (0832-6045-15) 0832-6045-50 50 mL in 1 BOTTLE (0832-6045-50)

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": "266982a6-6b63-69ae-e063-6394a90af64a", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310274"], "spl_set_id": ["d528fadf-316f-4fea-9bec-070c01f80d64"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0832-6045-10)", "package_ndc": "0832-6045-10", "marketing_start_date": "20231027"}, {"sample": false, "description": "150 mL in 1 BOTTLE (0832-6045-15)", "package_ndc": "0832-6045-15", "marketing_start_date": "20231027"}, {"sample": false, "description": "50 mL in 1 BOTTLE (0832-6045-50)", "package_ndc": "0832-6045-50", "marketing_start_date": "20230711"}], "brand_name": "Famotidine", "product_id": "0832-6045_266982a6-6b63-69ae-e063-6394a90af64a", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0832-6045", "generic_name": "Famotidine", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/5mL"}], "application_number": "ANDA217655", "marketing_category": "ANDA", "marketing_start_date": "20230616", "listing_expiration_date": "20261231"}