famotidine

Generic: famotidine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

famotidine 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-738
Product ID 63323-738_14c82153-53c9-4457-8cd3-fbb045885412
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075709
Listing Expiration 2026-12-31
Marketing Start 2001-07-19

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 63323738
Hyphenated Format 63323-738

Supplemental Identifiers

RxCUI
204441
UPC
0363323738037 0363323738068
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 ANDA075709 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-09) / 4 mL in 1 VIAL, MULTI-DOSE (63323-738-03)
  • 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20) / 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06)
source: ndc

Packages (2)

63323-738-09 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-09) / 4 mL in 1 VIAL, MULTI-DOSE (63323-738-03) 63323-738-20 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20) / 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06)

Ingredients (1)

famotidine (10 mg/mL)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "14c82153-53c9-4457-8cd3-fbb045885412", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0363323738037", "0363323738068"], "unii": ["5QZO15J2Z8"], "rxcui": ["204441"], "spl_set_id": ["5995d726-f3f8-4c2d-af19-1b12e3f769c6"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-09)  / 4 mL in 1 VIAL, MULTI-DOSE (63323-738-03)", "package_ndc": "63323-738-09", "marketing_start_date": "20010719"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06)", "package_ndc": "63323-738-20", "marketing_start_date": "20010719"}], "brand_name": "Famotidine", "product_id": "63323-738_14c82153-53c9-4457-8cd3-fbb045885412", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "63323-738", "generic_name": "FAMOTIDINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/mL"}], "application_number": "ANDA075709", "marketing_category": "ANDA", "marketing_start_date": "20010719", "listing_expiration_date": "20261231"}