Carmustine

Orange BookSPL

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7128812690
1 KIT in 1 CARTON (71288-126-90) * 30 mL in 1 VIAL, SINGLE-DOSE (71288-124-30) * 3 mL in 1 VIAL (71288-125-03)

Annotations

Orange Book

A213460

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b9b47082-32ee-4abb-a7b2-52292894d3f8": {
      "match": "brand_token",
      "title": "CARMUSTINE (CARMUSTINE) KIT [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "4",
      "published_date": "2026-04-13"
    }
  },
  "productid": "71288-126_ddf050d8-5626-4ee0-99dd-bd44146b144e",
  "productndc": "71288-126",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213460",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 2, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Carmustine",
  "active_ingred_unit": null,
  "application_number": "ANDA213460",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carmustine",
  "start_marketing_date": "20210802",
  "active_numerator_strength": null
}

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