EVOMELA
- Product NDC
- 72893-001
- 11-digit product format
- 728930001
- Labeler code
- 72893
- Product ID
- 72893-001_4dd3db2d-aa56-4952-bcad-70fa22e8e93c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Melphalan
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Acrotech Biopharma Inc
- Application
- NDA207155
- Marketing category
- NDA
- Marketing start
- 2016-03-31
- Substance
- MELPHALAN HYDROCHLORIDE
- Active strength
- 50 mg/10mL
- 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
- EVOMELA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MELPHALAN HYDROCHLORIDE | 50 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1VXP4V453T |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72893-001-01 | EVOMELA | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 6 |
| 72893-001-01 | EVOMELA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72893-001 | EVOMELA (MELPHALAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230615_69f55869-dc11-408e-8fc7-47634269a52c.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 |
|---|
| 72893-001-01 | 72893000101 | 1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL | 1 vial | 2016-03-31 | 0000-00-00 | No | No | Current |