matulane

Generic: procarbazine hydrochloride

Labeler: leadiant biosciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name matulane
Generic Name procarbazine hydrochloride
Labeler leadiant biosciences, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

procarbazine hydrochloride 50 mg/1

Manufacturer
Leadiant Biosciences, Inc.

Identifiers & Regulatory

Product NDC 54482-054
Product ID 54482-054_caa705fa-c467-49b5-a7cb-ae2c8b872a86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016785
Listing Expiration 2026-12-31
Marketing Start 1985-12-27

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54482054
Hyphenated Format 54482-054

Supplemental Identifiers

RxCUI
207588 314167
UNII
XH0NPH5ZX8

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name matulane (source: ndc)
Generic Name procarbazine hydrochloride (source: ndc)
Application Number NDA016785 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (54482-054-01)
source: ndc

Packages (1)

54482-054-01 100 CAPSULE in 1 BOTTLE (54482-054-01)

Ingredients (1)

procarbazine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Matulane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "caa705fa-c467-49b5-a7cb-ae2c8b872a86", "openfda": {"unii": ["XH0NPH5ZX8"], "rxcui": ["207588", "314167"], "spl_set_id": ["1aa75a3a-18c9-49e1-91a6-293d0b7da756"], "manufacturer_name": ["Leadiant Biosciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (54482-054-01)", "package_ndc": "54482-054-01", "marketing_start_date": "19851227"}], "brand_name": "Matulane", "product_id": "54482-054_caa705fa-c467-49b5-a7cb-ae2c8b872a86", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "54482-054", "generic_name": "procarbazine hydrochloride", "labeler_name": "Leadiant Biosciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Matulane", "active_ingredients": [{"name": "PROCARBAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "NDA016785", "marketing_category": "NDA", "marketing_start_date": "19851227", "listing_expiration_date": "20261231"}