Prescription drug · ANDA
Montelukast NDC 0781-5560
Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5560-13 | 00781556013 | 10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)Marketed from Jun 13, 2025 | |
| 0781-5560-31 | 00781556031 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)Marketed from Jun 13, 2025 | |
| 0781-5560-92 | 00781556092 | 90 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)Marketed from Jun 13, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Montelukast
- Generic name (nonproprietary)
- montelukast
- Active ingredients
- Montelukast sodium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200889
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7SPL ID e593fadb-cac5-44ca-8fd6-93c626cd40a7SPL set ID 6d69e73a-76cb-4ece-9cf9-e9adb4f523b4RxCUI 200224UNII U1O3J18SFLUPC 0307815560317
- Pharmacologic class
- Leukotriene Receptor Antagonist
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
N400781556013followed by a unit qualifier and the quantityPackage 00781-5560-13. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.