carmustine

Orange BookSPL

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012114822
1 KIT in 1 CARTON (70121-1482-2) * 3 mL in 1 VIAL (70121-3639-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70121-1668-1)

Annotations

Orange Book

A211229

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": "70121-1482_811400a5-1133-45dc-8b6f-23e74c92d206",
  "productndc": "70121-1482",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211229",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "carmustine",
  "active_ingred_unit": null,
  "application_number": "ANDA211229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carmustine",
  "start_marketing_date": "20181022",
  "active_numerator_strength": null
}

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