Prescription drug · NDA
Gleostine (Lomustine) NDC 58181-3041
Lomustine 40 mg/1 · Capsule, Gelatin coated · Oral · NextSource Biotechnology, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58181-3041-5 | 58181304105 | 1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Aug 18, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Gleostine
- Generic name (nonproprietary)
- lomustine
- Active ingredients
- Lomustine — 40 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- NextSource Biotechnology, LLCNDC labeler code 58181
- 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 58181-3041_0fa10522-2034-c417-e063-6394a90a2cf5SPL ID 0fa10522-2034-c417-e063-6394a90a2cf5SPL set ID 7f77526b-4c40-409c-82ea-d0f934d89cc2RxCUI 197894, 197895, 197896, 1545776, 1545778, 1545780UNII 7BRF0Z81KG
- 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
N458181304105followed by a unit qualifier and the quantityPackage 58181-3041-05. 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)
Gleostine 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 Gleostine 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 Gleostine 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.
About NDC 58181-3041
- What is NDC 58181-3041?
- 58181-3041 is the product NDC for Gleostine (lomustine), Lomustine 40 mg/1 capsule, gelatin coated, listed with the FDA by NextSource Biotechnology, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gleostine (Lomustine).
- What is the active ingredient?
- Lomustine.
- Who is the labeler?
- NextSource Biotechnology, LLC, NDC labeler code 58181. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gleostine?
- 5 other product NDCs are listed under this name. See all Gleostine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gleostine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gleostinelomustine | Lomustine 10 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-340 | 24338-0340-05 |
| Gleostinelomustine | Lomustine 40 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-341 | 24338-0341-05 |
| Gleostinelomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-342 | 24338-0342-05 |
| Gleostinelomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | NextSource Biotechnology, LLC | 58181-3042 | 58181-3042-05 |
| Gleostinelomustine | Lomustine 10 mg/1 | Capsule, Gelatin coatedOral | NextSource Biotechnology, LLC | 58181-3040 | 58181-3040-05 |
Other NDCs under NDA 017588
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 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-340 |
| Lomustine | Lomustine 40 mg/1 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-341 |
| Lomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | Wilshire Pharmaceuticals, Inc. | 52536-342 |
| Gleostinelomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | NextSource Biotechnology, LLC | 58181-3042 |
| Gleostinelomustine | Lomustine 10 mg/1 | Capsule, Gelatin coatedOral | NextSource Biotechnology, LLC | 58181-3040 |
| Gleostinelomustine | Lomustine 10 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-340 |
| Gleostinelomustine | Lomustine 40 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-341 |
| Gleostinelomustine | Lomustine 100 mg/1 | Capsule, Gelatin coatedOral | Azurity Pharmaceuticals, Inc. | 24338-342 |