Prescription drug · ANDA
Montelukast Sodium NDC 0904-6808
Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6808-06 | 00904680806 | 50 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2014 | |
| 0904-6808-61 | 00904680861 | 100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2014 |
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 Sodium
- Generic name (nonproprietary)
- montelukast sodium
- Active ingredients
- Montelukast sodium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202843
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500bSPL ID 4a289de2-d2e7-416d-9168-7f79cbff500bSPL set ID a4dc63cf-8145-42f4-9437-93b414d2aed4RxCUI 200224UNII U1O3J18SFL
- 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
N400904680806followed by a unit qualifier and the quantityPackage 00904-6808-06. 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.
Other NDCs under ANDA 202843
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 |
|---|---|---|---|---|
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-556 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8075 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-418 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8099 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-563 |
| Montelukastmontelukast sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6109 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6108 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-175 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3133 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1979 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-009 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-726 |