Prescription drug · ANDA
Montelukast Sodium NDC 27241-016
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-016-03 | 27241001603 | 30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)Marketed from Aug 13, 2015 | |
| 27241-016-09 | 27241001609 | 90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)Marketed from Aug 13, 2015 |
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
- Ajanta Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203328
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 27241-016_c7998daa-0220-4f57-a2b7-a2e468b10471SPL ID c7998daa-0220-4f57-a2b7-a2e468b10471SPL set ID 67070e4e-f755-46b3-b900-fcc1993a0546RxCUI 200224, 242438, 311759, 351246UNII U1O3J18SFLUPC 0327241016035, 0327241018039, 0327241018091, 0327241017094, 0327241016097, 0327241017032
- 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
N427241001603followed by a unit qualifier and the quantityPackage 27241-0016-03. 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)
Montelukast sodium tablets, chewable tablets, and oral granules are 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. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Ast…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203328
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 Sodiummontelukast | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Ajanta Pharma USA Inc. | 27241-017 |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 63187-751 |
| Montelukast Sodiummontelukast | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 71205-128 |