Ceftriaxone Sodium

Orange BookUNIISPLATC J01DD04

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01DD04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8280406601
1 VIAL, SINGLE-USE in 1 CARTON (82804-066-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
ndc11
8280406610
10 VIAL, SINGLE-USE in 1 CARTON (82804-066-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

023Z5BR09K

CEFTRIAXONE SODIUM

RxCUI 203172

Orange Book

A203702

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": "82804-066_790279d4-2456-4091-abec-960b78885432",
  "productndc": "82804-066",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203702",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jun 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jun 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTRIAXONE SODIUM",
  "proprietary_name": "Ceftriaxone Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ceftriaxone Sodium",
  "start_marketing_date": "20170630",
  "active_numerator_strength": "500"
}

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