leukeran

Generic: chlorambucil

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

Drug Facts

Product Profile

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

chlorambucil 2 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-610
Product ID 80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA010669
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 80725610
Hyphenated Format 80725-610

Supplemental Identifiers

RxCUI
105553 197462
UNII
18D0SL7309
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 leukeran (source: ndc)
Generic Name chlorambucil (source: ndc)
Application Number NDA010669 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)
source: ndc

Packages (1)

80725-610-25 25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)

Ingredients (1)

chlorambucil (2 mg/1)

Linked Drug Pages (1)

LEUKERAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5a3f7aed-1747-4c52-9e10-5aa090dd088e", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["18D0SL7309"], "rxcui": ["105553", "197462"], "spl_set_id": ["58a3c995-5ad6-465d-8437-5970c9088213"], "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 (80725-610-25)", "package_ndc": "80725-610-25", "marketing_start_date": "20230515"}], "brand_name": "LEUKERAN", "product_id": "80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "80725-610", "generic_name": "chlorambucil", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEUKERAN", "active_ingredients": [{"name": "CHLORAMBUCIL", "strength": "2 mg/1"}], "application_number": "NDA010669", "marketing_category": "NDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}