Prescription drug · ANDA
Lomustine NDC 80005-115
Lomustine 40 mg/1 · Capsule · Oral · Carnegie Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-115-02 | 80005011502 | 5 CAPSULE in 1 BOTTLE (80005-115-02)Marketed from Nov 10, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lomustine
- Generic name (nonproprietary)
- lomustine
- Active ingredients
- Lomustine — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Carnegie Pharmaceuticals LLCNDC labeler code 80005
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219265
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 80005-115_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2SPL ID 42672c94-b4e6-4bb8-b6b4-7c429acd7ea2SPL set ID 916dfac8-da11-40e4-9e44-a909e29a6b5fRxCUI 197894, 197895, 197896UNII 7BRF0Z81KGUPC 0380005116020
- Pharmacologic class
- Alkylating Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480005011502followed by a unit qualifier and the quantityPackage 80005-0115-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lomustine Capsules are an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. (1) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following i…
Excerpt only. Read the full label for complete information.
About NDC 80005-115
- What is NDC 80005-115?
- 80005-115 is the product NDC for Lomustine, Lomustine 40 mg/1 capsule, listed with the FDA by Carnegie Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lomustine.
- What is the active ingredient?
- Lomustine.
- Who is the labeler?
- Carnegie Pharmaceuticals LLC, NDC labeler code 80005. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lomustine?
- 5 other product NDCs are listed under this name. See all Lomustine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lomustine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lomustine | Lomustine 10 mg/1 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-340 | 52536-0340-05 |
| Lomustine | Lomustine 40 mg/1 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-341 | 52536-0341-05 |
| Lomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-342 | 52536-0342-05 |
| Lomustine | Lomustine 10 mg/1 | CapsuleOral | Carnegie Pharmaceuticals LLC | 80005-114 | 80005-0114-02 |
| Lomustine | Lomustine 100 mg/1 | CapsuleOral | Carnegie Pharmaceuticals LLC | 80005-116 | 80005-0116-02 |
Other NDCs under ANDA 219265
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lomustine | Lomustine 10 mg/1 | CapsuleOral | Carnegie Pharmaceuticals LLC | 80005-114 |
| Lomustine | Lomustine 100 mg/1 | CapsuleOral | Carnegie Pharmaceuticals LLC | 80005-116 |