Cefepime

In shortageOrange BookUNIISPLATC J01DE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeJ01DE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332334020
10 VIAL in 1 CARTON (63323-340-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-340-21)

Annotations

UNII (FDA Substance ID)

I8X1O0607P

CEFEPIME HYDROCHLORIDE

RxCUI 236058

Orange Book

A065441

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Cefepime Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "I8X1O0607P",
    "rxcui": "236058",
    "inchikey": "LRAJHPGSGBRUJN-OMIVUECESA-N",
    "display_name": "CEFEPIME HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c654ef2e-1067-4026-8931-6a0dc2a17ad1": {
      "match": "brand_token",
      "title": "CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
      "spl_version": "7",
      "published_date": "2026-04-23"
    }
  },
  "productid": "63323-340_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b",
  "productndc": "63323-340",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 20, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Mar 20, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFEPIME HYDROCHLORIDE",
  "shortage_reason": "Cefepime Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Cefepime",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA065441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefepime",
  "start_marketing_date": "20100830",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code J01DE.

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