Busulfan
- Product NDC
- 55150-395
- 11-digit product format
- 551500395
- Labeler code
- 55150
- Product ID
- 55150-395_06883ac0-4b2a-4f26-89bf-512d37b9ba7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA215102
- Marketing category
- ANDA
- Marketing start
- 2024-06-25
- 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 |
|---|
| 55150-395-01 | Busulfan | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 55150-395-08 | 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 |
|---|
| 55150-395 | BUSULFAN INJECTION, SOLUTION [EUGIA US LLC] | 1 | Current NDC, 2 package rows | 20240628_06883ac0-4b2a-4f26-89bf-512d37b9ba7f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-395-01 | 55150039501 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 55150-395-08 | 55150039508 | 8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01) | | 2024-06-25 | No | No | Current |