Prescription drug · ANDA
Montelukast Sodium (montelukast) NDC 71205-128
Montelukast sodium 5 mg/1 · Tablet, Chewable · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-128-30 | 71205012830 | 30 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30)Marketed from Oct 1, 2018 | |
| 71205-128-60 | 71205012860 | 60 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60)Marketed from Oct 1, 2018 | |
| 71205-128-90 | 71205012890 | 90 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90)Marketed from Oct 1, 2018 |
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
- Active ingredients
- Montelukast sodium — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-128_03b5d63d-1c2c-41db-8111-2dcf7e66f010SPL ID 03b5d63d-1c2c-41db-8111-2dcf7e66f010SPL set ID cab84c43-96a3-4868-88da-3126685edf00RxCUI 242438UNII 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
N471205012830followed by a unit qualifier and the quantityPackage 71205-0128-30. 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, 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 ( 1.3 ). 1.1 Asthma Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 1…
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 Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Ajanta Pharma USA Inc. | 27241-016 |
| 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 |