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United States · US · US:0338-5002_e6debc12-1f25-437c-970e-607f4953c7f7

Ceftriaxone

Orange BookUNIISPLATC J01DD04

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

Identification

ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC codeJ01DD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338500241
    24 BAG in 1 CASE (0338-5002-41) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
023Z5BR09K
CEFTRIAXONE SODIUM
RxCUI 203172
Orange Book
A065224
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "023Z5BR09K",
    "rxcui": "203172",
    "inchikey": "PMRZKYOXTPBIQF-MAODNAKNSA-J",
    "display_name": "CEFTRIAXONE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1": {
      "match": "brand_token",
      "title": "CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "26",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0338-5002_e6debc12-1f25-437c-970e-607f4953c7f7",
  "productndc": "0338-5002",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "065224",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE/ML",
        "product_no": "001",
        "approval_date": "Aug 23, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE/ML",
        "product_no": "002",
        "approval_date": "Aug 23, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTRIAXONE SODIUM",
  "proprietary_name": "Ceftriaxone",
  "active_ingred_unit": "g/50mL",
  "application_number": "ANDA065224",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ceftriaxone Sodium",
  "start_marketing_date": "20050823",
  "active_numerator_strength": "1"
}

Related drugs

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