cefepime hydrochloride

Generic: cefepime hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefepime hydrochloride
Generic Name cefepime hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cefepime hydrochloride 2 g/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9383
Product ID 0143-9383_c31d1803-2676-4944-92ef-0f6f5e3fee16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214402
Listing Expiration 2026-12-31
Marketing Start 2025-09-22

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439383
Hyphenated Format 0143-9383

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 hydrochloride (source: ndc)
Generic Name cefepime hydrochloride (source: ndc)
Application Number ANDA214402 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9383-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

0143-9383-10 10 VIAL in 1 CARTON (0143-9383-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (1)

cefepime hydrochloride (2 g/1)

Linked Drug Pages (1)

Cefepime Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c31d1803-2676-4944-92ef-0f6f5e3fee16", "openfda": {"unii": ["I8X1O0607P"], "rxcui": ["1665088", "1665093"], "spl_set_id": ["b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a01"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9383-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "0143-9383-10", "marketing_start_date": "20250922"}], "brand_name": "Cefepime Hydrochloride", "product_id": "0143-9383_c31d1803-2676-4944-92ef-0f6f5e3fee16", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0143-9383", "generic_name": "Cefepime Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefepime Hydrochloride", "active_ingredients": [{"name": "CEFEPIME HYDROCHLORIDE", "strength": "2 g/1"}], "application_number": "ANDA214402", "marketing_category": "ANDA", "marketing_start_date": "20250922", "listing_expiration_date": "20261231"}