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United States · US · US:0143-9878_4638263b-1c03-4a32-ba82-70270cf42490

Cefoxitin

Orange BookUNIISPLATC J01DC01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143987825
    25 VIAL in 1 CARTON (0143-9878-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9878-01)

Annotations

UNII (FDA Substance ID)
Q68050H03T
CEFOXITIN SODIUM
RxCUI 203118
Orange Book
A065238
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q68050H03T",
    "rxcui": "203118",
    "inchikey": "GNWUOVJNSFPWDD-XMZRARIVSA-M",
    "display_name": "CEFOXITIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "91ac4c14-8dd8-4efe-a462-d1c488a6184f": {
      "match": "brand_token",
      "title": "CEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0143-9878_4638263b-1c03-4a32-ba82-70270cf42490",
  "productndc": "0143-9878",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065238",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 12, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Mar 12, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFOXITIN SODIUM",
  "proprietary_name": "Cefoxitin",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA065238",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefoxitin",
  "start_marketing_date": "20100312",
  "active_numerator_strength": "1"
}

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