Prescription drug · ANDA
Montelukast Sodium NDC 72189-223
Montelukast 5 mg/1 · Tablet, Chewable · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-223-30 | 72189022330 | 30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30)Marketed from May 21, 2021 |
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 — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- DIRECT RX
- 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 72189-223_2c283d75-2454-ee48-e063-6294a90a7651SPL ID 2c283d75-2454-ee48-e063-6294a90a7651SPL set ID c2d834e6-7b38-d266-e053-2995a90a27efRxCUI 242438UNII MHM278SD3E
- 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
N472189022330followed by a unit qualifier and the quantityPackage 72189-0223-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neurops…
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 | Preferred Pharmaceuticals, Inc. | 68788-7669 |
| montelukast sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Bryant Ranch Prepack | 71335-1602 |