Prescription drug · ANDA
montelukast sodium NDC 71335-1602
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1602-1 | 71335160201 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1)Marketed from May 13, 2020 | |
| 71335-1602-2 | 71335160202 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2)Marketed from May 13, 2020 | |
| 71335-1602-3 | 71335160203 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3)Marketed from Feb 14, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204093
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227SPL ID 640b5606-8295-4f8d-9929-aedf2f51d227SPL set ID 3ff4100f-11e3-4d6a-ab88-83bd605a1818RxCUI 311759UNII 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
N471335160201followed by a unit qualifier and the quantityPackage 71335-1602-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years 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 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). 1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204093
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 5 mg/1 | Tablet, ChewableOral | Camber Pharmaceuticals, Inc. | 31722-728 |
| montelukast sodium | Montelukast 4 mg/1 | Tablet, ChewableOral | Camber Pharmaceuticals, Inc. | 31722-727 |
| montelukast sodium | Montelukast 4 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-2921 |
| montelukast sodium | Montelukast 4 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-7920 |
| montelukast sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-7925 |
| montelukast sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-4705 |
| Montelukast Sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | DIRECT RX | 72189-223 |
| montelukast sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | Preferred Pharmaceuticals, Inc. | 68788-7669 |