LOMUSTINE
- Product NDC
- 80005-115
- 11-digit product format
- 800050115
- Labeler code
- 80005
- Product ID
- 80005-115_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOMUSTINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Carnegie Pharmaceuticals LLC
- Application
- ANDA219265
- Marketing category
- ANDA
- Marketing start
- 2025-11-10
- Substance
- LOMUSTINE
- Active strength
- 40 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
- LOMUSTINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOMUSTINE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7BRF0Z81KG |
| Rxcui | 197894, 197895, 197896 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80005-115-02 | LOMUSTINE | 5 in 1 BOTTLE | CAPSULE | 5 | | 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 |
|---|
| 80005-115-02 | 80005011502 | 5 CAPSULE in 1 BOTTLE (80005-115-02) | 5 capsule | 2025-11-10 | No | No | Current |