LEUKERAN
- Product NDC
- 80725-610
- 11-digit product format
- 807250610
- Labeler code
- 80725
- Product ID
- 80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- chlorambucil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- NDA010669
- Marketing category
- NDA
- Marketing start
- 2023-05-15
- Substance
- CHLORAMBUCIL
- 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
- LEUKERAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORAMBUCIL | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 18D0SL7309 |
| Rxcui | 105553, 197462 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-610-25 | LEUKERAN | 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 |
|---|
| 80725-610 | LEUKERAN (CHLORAMBUCIL) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC] | 2 | Current NDC, 1 package rows | 20250110_58a3c995-5ad6-465d-8437-5970c9088213.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-610-25 | 80725061025 | 25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25) | 2023-05-15 | No | No | Current |