Gleostine
- Product NDC
- 24338-342
- 11-digit product format
- 243380342
- Labeler code
- 24338
- Product ID
- 24338-342_3529fe2f-3c23-4862-bb20-b48026957082
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lomustine
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA017588
- Marketing category
- NDA
- Marketing start
- 2025-10-24
- Substance
- LOMUSTINE
- Active strength
- 100 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
- Gleostine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOMUSTINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7BRF0Z81KG |
| Rxcui | 197894, 197895, 197896, 1545776, 1545778, 1545780 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-342-05 | Gleostine | 5 in 1 BOTTLE | CAPSULE, GELATIN COATED | 5 | | 1 |
| 24338-342-05 | Gleostine | 1 in 1 CARTON | CAPSULE, GELATIN COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 24338-342-05 | 24338034205 | 1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE | 1 bottle | 2025-10-24 | No | No | Historical |