Matulane

Product NDC
54482-053
11-digit product format
544820053
Labeler code
54482
Product ID
54482-053_97f59bac-2506-a98b-e053-2a95a90a8030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
procarbazine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sigma-Tau Pharmaceuticals, Inc.
Application
NDA016785
Marketing category
NDA
Marketing start
1985-12-27
Marketing end
2020-03-31
Substance
PROCARBAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54482-053DDiscontinued by firm2026-07-31
excluded packagepackage54482-05354482-053-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016785-001MATULANEPROCARBAZINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALRLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N016785-001MATULANEEQ 50MG BASECAPSULE / ORALRLD, RS, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MatulanePROCARBAZINE HYDROCHLORIDELeadiant Biosciences, Inc.1aa75a3a-18c9-49e1-91a6-293d0b7da7562024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016785
application number: NDA016785

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54482-053-01EA - Each54482-0530f4cda35-a574-4e64-8a78-3824b87fb40112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCARBAZINE HYDROCHLORIDEACTIVE INGREDIENTXH0NPH5ZX8MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
PROCARBAZINEACTIVE MOIETY35S93Y190KMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [SIGMA-TAU PHARMACEUTICALS, INC.]5