CARMUSTINE

Orange BookSPL

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

Identification

ManufacturerSandoz Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781347432
1 KIT in 1 CARTON (0781-3474-32) * 30 mL in 1 VIAL, SINGLE-DOSE (0781-3470-90) * 3 mL in 1 VIAL (0781-3473-93)

Annotations

Orange Book

A211202

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": "0781-3474_2f11b136-33d9-48a8-e063-6294a90a1d37",
  "productndc": "0781-3474",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211202",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Mar 12, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "CARMUSTINE",
  "active_ingred_unit": null,
  "application_number": "ANDA211202",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARMUSTINE",
  "start_marketing_date": "20210526",
  "active_numerator_strength": null
}

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