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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54482-053 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 54482-053 | 54482-053-01 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| 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 | 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.
| 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 | 016785 NDA016785 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54482-053-01 | EA - Each | 54482-053 | 0f4cda35-a574-4e64-8a78-3824b87fb401 | 1 | 2012-07-24 |