Busulfan
- Product NDC
- 65219-160
- 11-digit product format
- 652190160
- Labeler code
- 65219
- Product ID
- 65219-160_959759bf-825e-0cf4-e053-2a95a90a4d41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA210931
- Marketing category
- ANDA
- Marketing start
- 2019-11-11
- Marketing end
- 0000-00-00
- Substance
- BUSULFAN
- Active strength
- 6 mg/mL
- Pharmacologic classes
- Alkylating Activity [MoA],Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-160-10 | 65219016010 | 8 CARTON in 1 CARTON (65219-160-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-160-01) > 10 mL in 1 VIAL, SINGLE-DOSE | 8 carton | 2019-11-11 | 0000-00-00 | No | No | Current |