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United States · US · US:0143-9858_22f5b167-43fa-4fdf-9687-506a02e372e5

Ceftriaxone

Orange BookUNIISPLATC J01DD04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01DD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143985825
    25 VIAL in 1 BOX (0143-9858-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9858-01)

Annotations

UNII (FDA Substance ID)
023Z5BR09K
CEFTRIAXONE SODIUM
RxCUI 203172
Orange Book
A065342
APAPAPAP
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": "INTRAMUSCULAR; 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": "0143-9858_22f5b167-43fa-4fdf-9687-506a02e372e5",
  "productndc": "0143-9858",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065342",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 10, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 10, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jan 10, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jan 10, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTRIAXONE SODIUM",
  "proprietary_name": "Ceftriaxone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065342",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ceftriaxone",
  "start_marketing_date": "20080110",
  "active_numerator_strength": "500"
}

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