Busulfan
- Product NDC
- 72485-210
- 11-digit product format
- 724850210
- Labeler code
- 72485
- Product ID
- 72485-210_ae29e15b-df07-403f-8d07-f99e3ce501e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Busulfan
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA210931
- Marketing category
- ANDA
- Marketing start
- 2019-06-01
- 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 |
|---|
| 72485-210-01 | Busulfan | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 72485-210-08 | 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 |
|---|
| 72485-210 | BUSULFAN (BUSULFAN ) INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190607_4049d57f-342e-4233-8292-fed6b8f128ec.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 |
|---|
| 72485-210-01 | 72485021001 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 72485-210-08 | 72485021008 | 8 VIAL, SINGLE-DOSE in 1 CARTON (72485-210-08) / 10 mL in 1 VIAL, SINGLE-DOSE (72485-210-01) | | 2019-06-01 | 0000-00-00 | No | No | Current |