cefepime

Generic: cefepime

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefepime
Generic Name cefepime
Labeler baxter healthcare company
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cefepime hydrochloride 1 g/50mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-1301
Product ID 0338-1301_48ba7a5d-be02-4303-8a16-54352fbba703
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050817
Listing Expiration 2026-12-31
Marketing Start 2008-08-05

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03381301
Hyphenated Format 0338-1301

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 NDA050817 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/50mL
source: ndc
Packaging
  • 24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG
  • 12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG
source: ndc

Packages (2)

0338-1301-41 24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG 0338-1301-48 12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG

Ingredients (1)

cefepime hydrochloride (1 g/50mL)

Linked Drug Pages (1)

Cefepime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "48ba7a5d-be02-4303-8a16-54352fbba703", "openfda": {"unii": ["I8X1O0607P"], "rxcui": ["1665088", "1665093"], "spl_set_id": ["be5f8ca6-7232-423a-a2d5-cccb7abe7921"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 BOX (0338-1301-41)  / 50 mL in 1 BAG", "package_ndc": "0338-1301-41", "marketing_start_date": "20080805"}, {"sample": false, "description": "12 BAG in 1 BOX (0338-1301-48)  / 100 mL in 1 BAG", "package_ndc": "0338-1301-48", "marketing_start_date": "20080805"}], "brand_name": "Cefepime", "product_id": "0338-1301_48ba7a5d-be02-4303-8a16-54352fbba703", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0338-1301", "generic_name": "cefepime", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefepime", "active_ingredients": [{"name": "CEFEPIME HYDROCHLORIDE", "strength": "1 g/50mL"}], "application_number": "NDA050817", "marketing_category": "NDA", "marketing_start_date": "20080805", "listing_expiration_date": "20261231"}