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NDC 80725-0620-25 MYLERAN 2 mg/1 Details
MYLERAN 2 mg/1
MYLERAN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Waylis Therapeutics LLC. The primary component is BUSULFAN.
MedlinePlus Drug Summary
Busulfan is used treat a certain type of chronic myelogenous leukemia (CML; a type of cancer of the white blood cells). Busulfan is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 80725-0620-25Last Updated: 05/26/2024
MedLinePlus Full Drug Details: Busulfan
Product Information
| NDC | 80725-0620 |
|---|---|
| Product ID | 80725-620_f7df90c1-716d-47cd-b3ce-e1c3269edbb8 |
| Associated GPIs | |
| GCN Sequence Number | 008777 |
| GCN Sequence Number Description | busulfan TABLET 2 MG ORAL |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 38420 |
| HICL Sequence Number | 003899 |
| HICL Sequence Number Description | BUSULFAN |
| Brand/Generic | Brand |
| Proprietary Name | MYLERAN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | busulfan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | BUSULFAN |
| Labeler Name | Waylis Therapeutics LLC |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA009386 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 80725-0620-25 (80725062025)
| NDC Package Code | 80725-620-25 |
|---|---|
| Billing NDC | 80725062025 |
| Package | 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25) |
| Marketing Start Date | 2023-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |