Prescription drug · ANDA
Montelukast Sodium NDC 42291-622
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-622-10 | 42291062210 | 1000 TABLET, CHEWABLE in 1 BOTTLE (42291-622-10)Marketed from Aug 4, 2016 | |
| 42291-622-30 | 42291062230 | 30 TABLET, CHEWABLE in 1 BOTTLE (42291-622-30)Marketed from Jan 4, 2013 | |
| 42291-622-90 | 42291062290 | 90 TABLET, CHEWABLE in 1 BOTTLE (42291-622-90)Marketed from Jan 4, 2013 |
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 — 4 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200405
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 42291-622_4617d4b7-780e-f9ce-e063-6294a90aa00bSPL ID 4617d4b7-780e-f9ce-e063-6294a90aa00bSPL set ID ed2caffa-a75c-1c27-ae30-2d8280eaea7dRxCUI 200224, 242438, 311759UNII U1O3J18SFLUPC 0342291623101, 0342291623309
- 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
N442291062210followed by a unit qualifier and the quantityPackage 42291-0622-10. 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 .
Indications (excerpt from the label)
Montelukast sodium tablets is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (1.1) . Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2) . Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older (1.3) . 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200405
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 Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Chartwell RX, LLC | 62135-781 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Chartwell RX, LLC | 62135-782 |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | AvPAK | 50268-573 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | AvPAK | 50268-574 |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 71205-189 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | AvKARE | 42291-623 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 63187-896 |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Lannett Company, Inc. | 62175-204 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Lannett Company, Inc. | 62175-205 |