Cefotaxime

In shortageOrange BookUNIISPLATC J01DD

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ01DD

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143993125
25 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01)

Annotations

UNII (FDA Substance ID)

258J72S7TZ

CEFOTAXIME SODIUM

RxCUI 203117

Orange Book

A065072

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Cefotaxime Sodium Powder, for Solution

Raw payload (JSON)

{
  "unii": {
    "unii": "258J72S7TZ",
    "rxcui": "203117",
    "inchikey": "AZZMGZXNTDTSME-JUZDKLSSSA-M",
    "display_name": "CEFOTAXIME SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "8efe3bd0-c43a-2bd6-e053-2a95a90a92fa": {
      "match": "brand_token",
      "title": "CEFOTAXIME (CEFOTAXIME INJECTION) POWDER, FOR SOLUTION [STERIMAX INC.]",
      "spl_version": "6",
      "published_date": "2024-12-16"
    }
  },
  "productid": "0143-9931_7e0897ec-2275-4438-9cc5-4c951e52ad97",
  "productndc": "0143-9931",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065072",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 20, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Nov 20, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Nov 20, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFOTAXIME SODIUM",
  "shortage_reason": "Cefotaxime Sodium Powder, for Solution",
  "shortage_status": "current",
  "proprietary_name": "Cefotaxime",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA065072",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefotaxime",
  "start_marketing_date": "20021120",
  "active_numerator_strength": "1"
}

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