Prescription drug · ANDA
Montelukast NDC 70518-3133
Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3133-0 | 70518313300 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-0)Marketed from Jun 18, 2021 | |
| 70518-3133-1 | 70518313301 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3133-1)Marketed from Jul 1, 2021 | |
| 70518-3133-2 | 70518313302 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-2)Marketed from Aug 27, 2025 |
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
- Generic name (nonproprietary)
- montelukast
- Active ingredients
- Montelukast sodium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK 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 70518-3133_4e92e21f-c616-d5db-e063-6394a90aebccSPL ID 4e92e21f-c616-d5db-e063-6394a90aebccSPL set ID ecaa9b4b-5941-4af5-930c-35e9f3b2b4baRxCUI 200224UNII 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
N470518313300followed by a unit qualifier and the quantityPackage 70518-3133-00. 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 are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years 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 Asthma Montelukast sodium tablets are…
Excerpt only. Read the full label for complete information.
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 | Bryant Ranch Prepack | 71335-1979 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-009 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-726 |