MYLERAN
- Product NDC
- 69784-620
- 11-digit product format
- 697840620
- Labeler code
- 69784
- Product ID
- 69784-620_f68d65a9-9f60-4ff8-9eb4-36d86b364683
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- busulfan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Woodward Pharma Services LLC
- Application
- NDA009386
- Marketing category
- NDA
- Marketing start
- 2022-06-30
- Marketing end
- 0000-00-00
- Substance
- BUSULFAN
- Active strength
- 2 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69784-620 | MYLERAN (BUSULFAN) TABLET, FILM COATED [WOODWARD PHARMA SERVICES LLC] | 5 | Legacy NDC | 20221230_00ca5f69-8944-47f8-8ebf-98b0b8062c20.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69784-620-25 | 69784062025 | 25 TABLET, FILM COATED in 1 BOTTLE (69784-620-25) | 2022-06-30 | 0000-00-00 | No | No | Current |