Carmustine

Orange BookSPL

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

Identification

ManufacturerNavinta LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6847550301
1 KIT in 1 CARTON (68475-503-01) * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01)

Annotations

Orange Book

A210179

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": "68475-503_14b0f256-a380-424d-a9d4-fafb6ec0e246",
  "productndc": "68475-503",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "210179",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Carmustine",
  "active_ingred_unit": null,
  "application_number": "ANDA210179",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carmustine",
  "start_marketing_date": "20201229",
  "active_numerator_strength": null
}

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