NDC codes

FDA NDC Directory
Product NDC (as listed)80005-115Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80005-0115Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
80005-115-02800050115025 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

N480005011502 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lomustine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LomustineLomustine 10 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-34052536-0340-05
LomustineLomustine 40 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-34152536-0341-05
LomustineLomustine 100 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-34252536-0342-05
LomustineLomustine 10 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-11480005-0114-02
LomustineLomustine 100 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-11680005-0116-02

Other NDCs under ANDA 219265

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219265
ProductStrengthForm · routeLabelerProduct NDC
LomustineLomustine 10 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-114
LomustineLomustine 100 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-116

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