NDC codes

FDA NDC Directory
Product NDC (as listed)52536-341Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52536-0341Add 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
52536-341-0552536034105525360341051 BOTTLE in 1 CARTON (52536-341-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Apr 15, 2026

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, Gelatin coated
Route
Oral
Labeler
Wilshire Pharmaceuticals, Inc.NDC labeler code 52536
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017588
Marketing start
Listing expires
Other FDA classes
Alkylating Activity (Mechanism)
Identifiers
Product ID 52536-341_934ec2f1-8c3f-4978-b712-33e98c4295a5SPL ID 934ec2f1-8c3f-4978-b712-33e98c4295a5SPL set ID 3c3637fc-4499-4331-a3c4-6969fc86704eRxCUI 197894, 197895, 197896UNII 7BRF0Z81KGUPC 0352536341059, 0352536340052, 0352536342056
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

N452536034105 followed by a unit qualifier and the quantity

Package 52536-0341-05. 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 is 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 is 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 is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52536-341

What is NDC 52536-341?
52536-341 is the product NDC for Lomustine, Lomustine 40 mg/1 capsule, gelatin coated, listed with the FDA by Wilshire Pharmaceuticals, Inc.. 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?
Wilshire Pharmaceuticals, Inc., NDC labeler code 52536. 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 100 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-34252536-0342-05
LomustineLomustine 10 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-11480005-0114-02
LomustineLomustine 40 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-11580005-0115-02
LomustineLomustine 100 mg/1CapsuleOralCarnegie Pharmaceuticals LLC80005-11680005-0116-02

Other NDCs under NDA 017588

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

FDA NDC Directory listings under NDA 017588
ProductStrengthForm · routeLabelerProduct NDC
GleostinelomustineLomustine 10 mg/1Capsule, Gelatin coatedOralAzurity Pharmaceuticals, Inc.24338-340
GleostinelomustineLomustine 40 mg/1Capsule, Gelatin coatedOralAzurity Pharmaceuticals, Inc.24338-341
GleostinelomustineLomustine 100 mg/1Capsule, Gelatin coatedOralAzurity Pharmaceuticals, Inc.24338-342
GleostinelomustineLomustine 10 mg/1Capsule, Gelatin coatedOralNextSource Biotechnology, LLC58181-3040
GleostinelomustineLomustine 40 mg/1Capsule, Gelatin coatedOralNextSource Biotechnology, LLC58181-3041
GleostinelomustineLomustine 100 mg/1Capsule, Gelatin coatedOralNextSource Biotechnology, LLC58181-3042
LomustineLomustine 10 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-340
LomustineLomustine 100 mg/1Capsule, Gelatin coatedOralWilshire Pharmaceuticals, Inc.52536-342

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