CEFEPIME HYDROCHLORIDE AND DEXTROSE

In shortageOrange BookUNIISPLATC J01DE

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeJ01DE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0264319311
24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

I8X1O0607P

CEFEPIME HYDROCHLORIDE

RxCUI 236058

Orange Book

N050821

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": "0264-3193_8b4b5fb9-6be2-40c8-a8ef-60a9d7967e3e",
  "productndc": "0264-3193",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "050821",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 6, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "May 6, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFEPIME HYDROCHLORIDE",
  "shortage_reason": "Cefepime Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "CEFEPIME HYDROCHLORIDE AND DEXTROSE",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA050821",
  "marketing_category": "NDA",
  "nonproprietary_name": "CEFEPIME HYDROCHLORIDE",
  "start_marketing_date": "20100506",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code J01DE.

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