Melphalan hydrochloride
- Product NDC
- 54288-109
- 11-digit product format
- 542880109
- Labeler code
- 54288
- Product ID
- 54288-109_731e5310-a610-419d-bae0-89d4d2702731
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Melphalan Hydrochloride
- Dosage form
- KIT
- Labeler
- BPI Labs LLC
- Application
- ANDA209197
- Marketing category
- ANDA
- Marketing start
- 2021-07-02
- 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 |
|---|
| 54288-109-02 | Melphalan hydrochloride | 1 in 1 CARTON | KIT | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54288-109 | MELPHALAN HYDROCHLORIDE KIT [BPI LABS LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250213_dab93975-0587-4f12-848c-9130bb02d036.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 |
|---|
| 54288-109-02 | 54288010902 | 1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01) | 1 kit | 2021-07-02 | 0000-00-00 | No | No | Current |