Home NDC 54482-054 Matulane
Product NDC 54482-054
11-digit product format 544820054
Labeler code 54482
Product ID 54482-054_caa705fa-c467-49b5-a7cb-ae2c8b872a86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name procarbazine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Leadiant Biosciences, Inc.
Application NDA016785
Marketing category NDA
Marketing start 1985-12-27
Substance PROCARBAZINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016785-001 MATULANE PROCARBAZINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL RLD, 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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N016785-001 MATULANE EQ 50MG BASE CAPSULE / ORAL RLD, RS, Approved before 1982 a50c72e98297…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Matulane PROCARBAZINE HYDROCHLORIDE Leadiant Biosciences, Inc. 1aa75a3a-18c9-49e1-91a6-293d0b7da756 2024-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 016785 application number: NDA016785 ndc (product): 54482-054
Additional Listing Data#
Finished product Yes
Brand name base Matulane
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCARBAZINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XH0NPH5ZX8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207588 Internal RxNorm lookup 314167 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54482-054-01 Matulane 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54482-054 MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [LEADIANT BIOSCIENCES, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240925_1aa75a3a-18c9-49e1-91a6-293d0b7da756.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54482-054-01 54482005401 100 CAPSULE in 1 BOTTLE (54482-054-01) 100 capsule 1985-12-27 0000-00-00 No No Current