BUSULFEX
- Product NDC
- 59148-070
- 11-digit product format
- 591480070
- Labeler code
- 59148
- Product ID
- 59148-070_b281d2c1-122c-4a27-8a27-e222359c0fb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- busulfan
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- NDA020954
- Marketing category
- NDA
- Marketing start
- 1999-02-04
- 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
- BUSULFEX
- 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, 284425 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59148-070-90 | BUSULFEX | 10 mL in 1 VIAL | INJECTION | 10 | | 32 |
| 59148-070-90 | BUSULFEX | 1 in 1 CARTON | INJECTION | 1 | | 32 |
| 59148-070-91 | BUSULFEX | 8 in 1 CARTON | INJECTION | 8 | | 32 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59148-070 | BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.] | 31 | Current NDC, Legacy NDC, 3 package rows | 20231216_5cb9d285-1803-4a99-946a-d0b239b32df6.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 |
|---|
| 59148-070-90 | 59148007090 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 59148-070-91 | 59148007091 | 8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL | 8 carton | 1999-02-04 | 0000-00-00 | No | No | Current |