Melphalan hydrochloride
- Product NDC
- 68083-259
- 11-digit product format
- 680830259
- Labeler code
- 68083
- Product ID
- 68083-259_c1a5c2ee-7acc-44f6-8e95-534a2d88e223
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Melphalan hydrochloride
- Dosage form
- KIT
- Labeler
- Gland Pharma Limited
- Application
- ANDA209826
- Marketing category
- ANDA
- Marketing start
- 2019-06-10
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Melphalan hydrochloride
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 311487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-259-01 | Melphalan hydrochloride | 1 in 1 CARTON | KIT | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-259 | MELPHALAN HYDROCHLORIDE KIT [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20190610_ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0.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 |
|---|
| 68083-259-01 | 68083025901 | 1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01) | 1 kit | 2019-06-10 | 0000-00-00 | No | No | Current |