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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XH0NPH5ZX8 |
| Rxcui | 207588, 314167 |
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 |