Busulfan
- Product NDC
- 71288-158
- 11-digit product format
- 712880158
- Labeler code
- 71288
- Product ID
- 71288-158_598cecaa-f38c-451c-a3c8-55d90401b742
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA212127
- Marketing category
- ANDA
- Marketing start
- 2020-10-23
- 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 |
|---|
| 71288-158-95 | Busulfan | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 71288-158-96 | Busulfan | 8 in 1 CARTON | INJECTION, SOLUTION | 8 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-158 | BUSULFAN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210615_dc384f16-4e25-458e-874c-553f81c6d8c9.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 |
|---|
| 71288-158-95 | 71288015895 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 71288-158-96 | 71288015896 | 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-158-96) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-158-95) | | 2020-10-23 | 0000-00-00 | No | No | Current |