Busulfan
- Product NDC
- 16729-351
- 11-digit product format
- 167290351
- Labeler code
- 16729
- Product ID
- 16729-351_0e2ef789-efb4-8395-e063-6294a90a9145
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- busulfan
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc
- Application
- ANDA210148
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- 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 |
|---|
| 16729-351-03 | Busulfan | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 4 |
| 16729-351-92 | Busulfan | 8 in 1 CARTON | INJECTION | 8 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-351 | BUSULFAN INJECTION [ACCORD HEALTHCARE, INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240106_fe0ddd44-ef02-4827-b164-7fcbb45bcc1b.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 |
|---|
| 16729-351-03 | 16729035103 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 16729-351-92 | 16729035192 | 8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03) | | 2019-07-22 | 0000-00-00 | No | No | Current |