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United States · US · US:0143-9935_e25af43f-54cb-4526-a8a5-6bef0a7939c7

Cefotaxime

In shortageOrange BookUNIISPLATC J01DD

Last synced from FDA National Drug Code directory (United States) on

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
    0143993501
    1 INJECTION in 1 PACKAGE (0143-9935-01)

Annotations

UNII (FDA Substance ID)
258J72S7TZ
CEFOTAXIME SODIUM
RxCUI 203117
Orange Book
A065071
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": "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": "0143-9935_e25af43f-54cb-4526-a8a5-6bef0a7939c7",
  "productndc": "0143-9935",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "065071",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "001",
        "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": "ANDA065071",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefotaxime",
  "start_marketing_date": "20021120",
  "active_numerator_strength": "10"
}

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