NDC 69639-120

VALCHLOR

Mechlorethamine Hydrochloride

VALCHLOR is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Mechlorethamine.

• Product ID: 69639-120_15ed0eaf-4b85-45a9-b919-091487a338ac
• NDC: 69639-120
• Product Type: Human Prescription Drug
• Proprietary Name: VALCHLOR
• Generic Name: Mechlorethamine Hydrochloride
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-11-08
• Marketing Category: NDA / NDA
• Application Number: NDA202317
• Labeler Name: Helsinn Therapeutics (U.S.), Inc.
• Substance Name: MECHLORETHAMINE
• Active Ingredient Strength: 0 g/60g
• Pharm Classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 69639-120-01

1 TUBE in 1 CARTON (69639-120-01) > 60 g in 1 TUBE

• Marketing Start Date: 2018-11-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69639-120-01 [69639012001]

VALCHLOR GEL

• Marketing Category: NDA
• Application Number: NDA202317
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-11-08

Drug Details

Active Ingredients

Ingredient	Strength
MECHLORETHAMINE	.012 g/60g

OpenFDA Data

• SPL SET ID: 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
• Manufacturer:
  • Helsinn Therapeutics (U.S.), Inc.
• UNII:
  • 50D9XSG0VR
• RxNorm Concept Unique ID - RxCUI:
  • 1437711
  • 1437713
• UPC Code:
  • 0369639120016

Pharmacological Class

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

NDC Crossover Matching brand name "VALCHLOR" or generic name "Mechlorethamine Hydrochloride"

NDC	Brand Name	Generic Name
66215-016	VALCHLOR	mechlorethamine hydrochloride
69639-120	VALCHLOR	mechlorethamine hydrochloride
55292-911	Mustargen	mechlorethamine hydrochloride