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Matulane

MATULANE (procarbazine hydrochloride) Capsules

Approved
Approval ID

1aa75a3a-18c9-49e1-91a6-293d0b7da756

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers
FDA

Leadiant Biosciences, Inc.

DUNS: 068301431

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

procarbazine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54482-054
Application NumberNDA016785
Product Classification
M
Marketing Category
C73594
G
Generic Name
procarbazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (8)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROCARBAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: XH0NPH5ZX8
Classification: ACTIM

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Matulane - FDA Drug Approval Details