Busulfan
- Product NDC
- 25021-241
- 11-digit product format
- 250210241
- Labeler code
- 25021
- Product ID
- 25021-241_673100ef-2b51-4ba2-af5c-fe7c52220636
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA207050
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- Substance
- BUSULFAN
- Active strength
- 6 mg/mL
- 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
- Busulfan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUSULFAN | 6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G1LN9045DK |
| Rxcui | 253113 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-241-10 | Busulfan | 8 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 8 | | 6 |
| 25021-241-10 | Busulfan | 10 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-241 | BUSULFAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220412_086a715e-4958-4bb5-9ebd-86171e6b6203.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 |
|---|
| 25021-241-10 | 25021024110 | 8 VIAL in 1 CARTON (25021-241-10) / 10 mL in 1 VIAL | 8 vial | 2017-05-15 | 0000-00-00 | No | No | Current |