Prescription drug · ANDA
Montelukast Sodium NDC 31722-726
Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-726-01 | 31722072601 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01)Marketed from Sep 10, 2014 | |
| 31722-726-10 | 31722072610 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10)Marketed from Sep 10, 2014 | |
| 31722-726-30 | 31722072630 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-726-30)Marketed from Sep 10, 2014 | |
| 31722-726-32 | 31722072632 | 10 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31)Marketed from Sep 10, 2014 | |
| 31722-726-90 | 31722072690 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)Marketed from Sep 10, 2014 |
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)
- Montelukast Sodium
- Generic name (nonproprietary)
- montelukast sodium
- Active ingredients
- Montelukast sodium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- 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 31722-726_30387eb8-222d-146e-e063-6294a90a12a7SPL ID 30387eb8-222d-146e-e063-6294a90a12a7SPL set ID 97a682c2-7e00-4d07-a5ac-4436c977f842RxCUI 200224UNII U1O3J18SFLUPC 0331722726306
- 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
N431722072601followed by a unit qualifier and the quantityPackage 31722-0726-01. 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 Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6808 |
| 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 |