Ceftaroline Fosamil

Orange BookUNIISPLATC J01DI02

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeJ01DI02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050561251
10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6125-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6125-0)

Annotations

UNII (FDA Substance ID)

7P6FQA5D21

CEFTAROLINE FOSAMIL

RxCUI 1040004

Orange Book

A208075

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7P6FQA5D21",
    "rxcui": "1040004",
    "inchikey": "ZCCUWMICIWSJIX-NQJJCJBVSA-N",
    "display_name": "CEFTAROLINE FOSAMIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3cee3c08-ed60-06c5-ac49-103b7ad2ef5f": {
      "match": "brand_token",
      "title": "CEFTAROLINE FOSAMIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.]",
      "spl_version": "6",
      "published_date": "2026-02-16"
    }
  },
  "productid": "60505-6125_009f5e49-4075-974b-1178-42875743658a",
  "productndc": "60505-6125",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "400MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "600MG/VIAL",
        "product_no": "002",
        "approval_date": "Sep 21, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTAROLINE FOSAMIL",
  "proprietary_name": "Ceftaroline Fosamil",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA208075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ceftaroline Fosamil",
  "start_marketing_date": "20260212",
  "active_numerator_strength": "600"
}

Related drugs

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