NDC 63323-128

Dacarbazine

Dacarbazine

Dacarbazine is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Dacarbazine.

Product ID63323-128_04644165-06c9-4a55-a026-a529d824cc90
NDC63323-128
Product TypeHuman Prescription Drug
Proprietary NameDacarbazine
Generic NameDacarbazine
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2001-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA075371
Labeler NameFresenius Kabi USA, LLC
Substance NameDACARBAZINE
Active Ingredient Strength10 mg/mL
Pharm ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-128-20

10 VIAL, SINGLE-DOSE in 1 TRAY (63323-128-20) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-128-00)
Marketing Start Date2001-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-128-20 [63323012820]

Dacarbazine INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA075371
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-09-07

Drug Details

Active Ingredients

IngredientStrength
DACARBAZINE10 mg/mL

OpenFDA Data

SPL SET ID:b6b97e41-5f15-498c-abfb-d8443ea4d216
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1731340
  • 1731338
  • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

    NDC Crossover Matching brand name "Dacarbazine" or generic name "Dacarbazine"

    NDCBrand NameGeneric Name
    0143-9245DacarbazineDacarbazine
    0703-5075DacarbazineDacarbazine
    61703-327DacarbazineDACARBAZINE
    63323-127DacarbazineDACARBAZINE
    63323-128DacarbazineDACARBAZINE

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