Teflaro

Orange BookUNIISPLATC J01DI02

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

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC codeJ01DI02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0456040010
10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)

Annotations

UNII (FDA Substance ID)

7P6FQA5D21

CEFTAROLINE FOSAMIL

RxCUI 1040004

Orange Book

N200327

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": {
    "3ecde48b-75a2-4beb-9999-369f3f61bb8a": {
      "match": "brand_token",
      "title": "TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [ALLERGAN, INC.]",
      "spl_version": "43",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4",
  "productndc": "0456-0400",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "200327",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "400MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 29, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "600MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 29, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTAROLINE FOSAMIL",
  "proprietary_name": "Teflaro",
  "active_ingred_unit": "mg/20mL",
  "application_number": "NDA200327",
  "marketing_category": "NDA",
  "nonproprietary_name": "ceftaroline fosamil",
  "start_marketing_date": "20101029",
  "active_numerator_strength": "400"
}

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