NDC 66215-016

VALCHLOR

Mechlorethamine Hydrochloride

VALCHLOR is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Mechlorethamine.

• Product ID: 66215-016_6315be05-3669-4a64-af95-3961b25c8c93
• NDC: 66215-016
• Product Type: Human Prescription Drug
• Proprietary Name: VALCHLOR
• Generic Name: Mechlorethamine Hydrochloride
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-10-21
• Marketing End Date: 2020-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA202317
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: MECHLORETHAMINE
• Active Ingredient Strength: 0 g/60g
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N

Packaging

NDC 66215-016-60

1 TUBE in 1 CARTON (66215-016-60) > 60 g in 1 TUBE

• Marketing Start Date: 2013-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-016-60 [66215001660]

VALCHLOR GEL

• Marketing Category: NDA
• Application Number: NDA202317
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2013-10-21
• Marketing End Date: 2020-05-31

Drug Details

Active Ingredients

Ingredient	Strength
MECHLORETHAMINE	.012 g/60g

OpenFDA Data

• SPL SET ID: f522cd6d-aa0f-4b44-92cc-ed952058eea0
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • 50D9XSG0VR
• RxNorm Concept Unique ID - RxCUI:
  • 1437711
  • 1437713

Pharmacological Class

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