MYLERAN
- Product NDC
- 80725-620
- 11-digit product format
- 807250620
- Labeler code
- 80725
- Product ID
- 80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- busulfan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- NDA009386
- Marketing category
- NDA
- Marketing start
- 2023-05-15
- Substance
- BUSULFAN
- Active strength
- 2 mg/1
- 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
- MYLERAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUSULFAN | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G1LN9045DK |
| Rxcui | 105551, 197422 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-620-25 | MYLERAN | 25 in 1 BOTTLE | TABLET, FILM COATED | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80725-620 | MYLERAN (BUSULFAN) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC] | 2 | Current NDC, 1 package rows | 20250110_2da33e5b-dcfb-4cdf-b163-50398e42f41c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-620-25 | 80725062025 | 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25) | 2023-05-15 | No | No | Current |