NDC 63323-127

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 ID: 63323-127_04644165-06c9-4a55-a026-a529d824cc90
• NDC: 63323-127
• Product Type: Human Prescription Drug
• Proprietary Name: Dacarbazine
• Generic Name: Dacarbazine
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2001-09-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075371
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: DACARBAZINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63323-127-10

10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) > 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)

• Marketing Start Date: 2001-09-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-127-10 [63323012710]

Dacarbazine INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075371
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-09-07

Drug Details

Active Ingredients

Ingredient	Strength
DACARBAZINE	10 mg/mL

OpenFDA Data

• SPL SET ID: b6b97e41-5f15-498c-abfb-d8443ea4d216
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 7GR28W0FJI
• 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"

NDC	Brand Name	Generic Name
0143-9245	Dacarbazine	Dacarbazine
0703-5075	Dacarbazine	Dacarbazine
61703-327	Dacarbazine	DACARBAZINE
63323-127	Dacarbazine	DACARBAZINE
63323-128	Dacarbazine	DACARBAZINE