NDC 54482-053

Matulane

Procarbazine Hydrochloride

Matulane is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sigma-tau Pharmaceuticals, Inc.. The primary component is Procarbazine Hydrochloride.

• Product ID: 54482-053_2ad0d8b4-f587-4ad2-b8a3-578f8fa61106
• NDC: 54482-053
• Product Type: Human Prescription Drug
• Proprietary Name: Matulane
• Generic Name: Procarbazine Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1985-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA016785
• Labeler Name: Sigma-Tau Pharmaceuticals, Inc.
• Substance Name: PROCARBAZINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54482-053-01

100 CAPSULE in 1 BOTTLE (54482-053-01)

• Marketing Start Date: 1985-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54482-053-01 [54482005301]

Matulane CAPSULE

• Marketing Category: NDA
• Application Number: NDA016785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1985-12-27
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
PROCARBAZINE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: de1c8271-64d8-4ea5-85e8-871faa4d7632
• Manufacturer:
  • Sigma-Tau Pharmaceuticals, Inc.
• UNII:
  • XH0NPH5ZX8
• RxNorm Concept Unique ID - RxCUI:
  • 314167
  • 207588

Pharmacological Class

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

NDC Crossover Matching brand name "Matulane" or generic name "Procarbazine Hydrochloride"

NDC	Brand Name	Generic Name
54482-053	Matulane	procarbazine hydrochloride
54482-054	Matulane	procarbazine hydrochloride