NDC 0703-5075

Dacarbazine

Dacarbazine

Dacarbazine is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Dacarbazine.

Product ID0703-5075_18c40b0d-0497-4ce4-acd1-6b072c359de1
NDC0703-5075
Product TypeHuman Prescription Drug
Proprietary NameDacarbazine
Generic NameDacarbazine
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1998-08-27
Marketing CategoryANDA / ANDA
Application NumberANDA075259
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameDACARBAZINE
Active Ingredient Strength200 mg/20mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0703-5075-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0703-5075-01) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1998-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-5075-01 [00703507501]

Dacarbazine INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA075259
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-27

NDC 0703-5075-03 [00703507503]

Dacarbazine INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA075259
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-27

Drug Details

Active Ingredients

IngredientStrength
DACARBAZINE200 mg/20mL

OpenFDA Data

SPL SET ID:26e91082-7698-4680-beab-07c47802f0f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1731338
  • UPC Code
  • 0307035075011
  • 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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