Carmustine

Orange BookSPL

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

Identification

ManufacturerKVK-Tech, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1070236199
1 KIT in 1 CARTON (10702-361-99) * 30 mL in 1 VIAL, SINGLE-DOSE (10702-366-03) * 3 mL in 1 VIAL (10702-365-03)

Annotations

Orange Book

A209278

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": "10702-361_4391d4c2-6430-85f9-e063-6394a90a90c1",
  "productndc": "10702-361",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 2, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Carmustine",
  "active_ingred_unit": null,
  "application_number": "ANDA209278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carmustine",
  "start_marketing_date": "20240301",
  "active_numerator_strength": null
}

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