GRAFAPEX
- Product NDC
- 59137-335
- 11-digit product format
- 591370335
- Labeler code
- 59137
- Product ID
- 59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- treosulfan
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Medexus Pharma, Inc.
- Application
- NDA214759
- Marketing category
- NDA
- Marketing start
- 2025-01-28
- Substance
- TREOSULFAN
- Active strength
- 1000 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GRAFAPEX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TREOSULFAN | 1000 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CO61ER3EPI |
| Rxcui | 2703570, 2703575, 2703577, 2703579 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59137-335-01 | GRAFAPEX | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 59137-335-01 | GRAFAPEX | 1 g in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59137-335 | GRAFAPEX (TREOSULFAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDEXUS PHARMA, INC.] | 1 | Current NDC, 2 package rows | 20250202_2d06b03c-17aa-0492-e063-6294a90abd8f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59137-335-01 | 59137033501 | 1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL | 1 vial | 2025-01-28 | No | No | Current |