Carmustine

Orange BookSPL

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4670865902
1 KIT in 1 CARTON (46708-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (46708-658-31) * 3 mL in 1 VIAL (46708-660-03)

Annotations

Orange Book

A215730

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "46708-659_6e0cfe79-6998-45b2-bceb-f8848624be5a",
  "productndc": "46708-659",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215730",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 20, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Carmustine",
  "active_ingred_unit": null,
  "application_number": "ANDA215730",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carmustine",
  "start_marketing_date": "20231020",
  "active_numerator_strength": null
}

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