Busulfan
- Product NDC
- 67457-893
- 11-digit product format
- 674570893
- Labeler code
- 67457
- Product ID
- 67457-893_2ddd71e8-c2bd-4ee9-bef3-14891809fa28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA208536
- Marketing category
- ANDA
- Marketing start
- 2017-11-21
- Marketing end
- 2026-05-31
- Substance
- BUSULFAN
- Active strength
- 6 mg/mL
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-893-00 | Busulfan | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 6 |
| 67457-893-08 | Busulfan | 8 in 1 CARTON | INJECTION | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-893 | BUSULFAN INJECTION [MYLAN INSTITUTIONAL LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20201104_9955aced-ac32-43e6-b39a-c6c023a50dc3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-893-00 | 67457089300 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 67457-893-08 | 67457089308 | 8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00) | | 2017-11-21 | 2026-05-31 | No | No | Current |