Prescription drug · ANDA
montelukast sodium NDC 31722-728
Montelukast 5 mg/1 · Tablet, Chewable · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-728-01 | 31722072801 | 100 TABLET, CHEWABLE in 1 BOTTLE (31722-728-01)Marketed from May 27, 2015 | |
| 31722-728-10 | 31722072810 | 1000 TABLET, CHEWABLE in 1 BOTTLE (31722-728-10)Marketed from May 27, 2015 | |
| 31722-728-30 | 31722072830 | 30 TABLET, CHEWABLE in 1 BOTTLE (31722-728-30)Marketed from May 27, 2015 | |
| 31722-728-31 | 31722072831 | 10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-728-31)Marketed from May 27, 2015 | |
| 31722-728-32 | 31722072832 | 100 TABLET, CHEWABLE in 1 CARTON (31722-728-32)Marketed from May 27, 2015 | |
| 31722-728-90 | 31722072890 | 90 TABLET, CHEWABLE in 1 BOTTLE (31722-728-90)Marketed from May 27, 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 — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- 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 31722-728_c503ea71-c663-3cfc-e053-2a95a90a9aaaSPL ID c503ea71-c663-3cfc-e053-2a95a90a9aaaSPL set ID 23964723-2df8-4d0a-a53d-8538469672f1RxCUI 242438, 311759UNII MHM278SD3EUPC 0331722727303, 0331722728300
- 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
N431722072801followed by a unit qualifier and the quantityPackage 31722-0728-01. 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 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 |
| montelukast sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Bryant Ranch Prepack | 71335-1602 |