Busulfan
- Product NDC
- 51817-170
- 11-digit product format
- 518170170
- Labeler code
- 51817
- Product ID
- 51817-170_df501797-3c7e-5ae2-e053-2995a90a99e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- busulfan
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Pharmascience Inc.
- Application
- ANDA207050
- Marketing category
- ANDA
- Marketing start
- 2017-05-19
- 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 |
|---|
| 51817-170-01 | Busulfan | 10 mL in 1 VIAL | INJECTION | 10 | | 6 |
| 51817-170-01 | Busulfan | 8 in 1 PACKAGE | INJECTION | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51817-170 | BUSULFAN INJECTION [PHARMASCIENCE INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220520_d0fe44f9-7747-4909-b927-3b24aa6e7e09.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 |
|---|
| 51817-170-01 | 51817017001 | 8 VIAL in 1 PACKAGE (51817-170-01) / 10 mL in 1 VIAL | 8 vial | 2017-05-19 | 0000-00-00 | No | No | Current |