cefepime

Generic: cefepime

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

Drug Facts

Product Profile

Brand Name cefepime
Generic Name cefepime
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

cefepime hydrochloride 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-326
Product ID 63323-326_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065441
Listing Expiration 2026-12-31
Marketing Start 2010-08-30

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323326
Hyphenated Format 63323-326

Supplemental Identifiers

RxCUI
1665088 1665093
UNII
I8X1O0607P

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 cefepime (source: ndc)
Generic Name cefepime (source: ndc)
Application Number ANDA065441 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (63323-326-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21)
source: ndc

Packages (1)

63323-326-20 10 VIAL in 1 CARTON (63323-326-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21)

Ingredients (1)

cefepime hydrochloride (1 g/1)

Linked Drug Pages (1)

Cefepime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "8c2fbf43-34bd-49d1-bda8-a2191c8bc54b", "openfda": {"unii": ["I8X1O0607P"], "rxcui": ["1665088", "1665093"], "spl_set_id": ["5e1695e0-1310-4cd8-a5da-ad1a7dcd1792"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (63323-326-20)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21)", "package_ndc": "63323-326-20", "marketing_start_date": "20100830"}], "brand_name": "Cefepime", "product_id": "63323-326_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "63323-326", "generic_name": "Cefepime", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefepime", "active_ingredients": [{"name": "CEFEPIME HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA065441", "marketing_category": "ANDA", "marketing_start_date": "20100830", "listing_expiration_date": "20261231"}