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 ID54482-053_2ad0d8b4-f587-4ad2-b8a3-578f8fa61106
NDC54482-053
Product TypeHuman Prescription Drug
Proprietary NameMatulane
Generic NameProcarbazine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1985-12-27
Marketing CategoryNDA / NDA
Application NumberNDA016785
Labeler NameSigma-Tau Pharmaceuticals, Inc.
Substance NamePROCARBAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54482-053-01

100 CAPSULE in 1 BOTTLE (54482-053-01)
Marketing Start Date1985-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54482-053-01 [54482005301]

Matulane CAPSULE
Marketing CategoryNDA
Application NumberNDA016785
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-12-27
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
PROCARBAZINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:de1c8271-64d8-4ea5-85e8-871faa4d7632
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    54482-053Matulaneprocarbazine hydrochloride
    54482-054Matulaneprocarbazine hydrochloride

    Trademark Results [Matulane]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MATULANE
    MATULANE
    72333132 0897704 Live/Registered
    HOFFMANN-LA ROCHE INC.
    1969-07-22

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.