myleran

Generic: busulfan

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name myleran
Generic Name busulfan
Labeler waylis therapeutics llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

busulfan 2 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-620
Product ID 80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA009386
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725620
Hyphenated Format 80725-620

Supplemental Identifiers

RxCUI
105551 197422
UNII
G1LN9045DK
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name myleran (source: ndc)
Generic Name busulfan (source: ndc)
Application Number NDA009386 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)
source: ndc

Packages (1)

80725-620-25 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)

Ingredients (1)

busulfan (2 mg/1)

Linked Drug Pages (1)

MYLERAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "da6a0ae8-6165-4e4f-b759-600cd940d252", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["105551", "197422"], "spl_set_id": ["2da33e5b-dcfb-4cdf-b163-50398e42f41c"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)", "package_ndc": "80725-620-25", "marketing_start_date": "20230515"}], "brand_name": "MYLERAN", "product_id": "80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "80725-620", "generic_name": "busulfan", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYLERAN", "active_ingredients": [{"name": "BUSULFAN", "strength": "2 mg/1"}], "application_number": "NDA009386", "marketing_category": "NDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}