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United States · US · US:70710-1525_b25715f6-a539-45de-b351-04e24649fb58

carmustine

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7071015259
    1 KIT in 1 CARTON (70710-1525-9) * 3 mL in 1 VIAL (70710-1523-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70710-1524-1)

Annotations

Orange Book
A210179
AP
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": "70710-1525_b25715f6-a539-45de-b351-04e24649fb58",
  "productndc": "70710-1525",
  "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": "20201224",
  "active_numerator_strength": null
}

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