Prescription drug · ANDA
Montelukast Sodium NDC 65862-567
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-567-05 | 6586205670565862056705 | 500 TABLET, CHEWABLE in 1 BOTTLE (65862-567-05)Marketed from Aug 3, 2012 | |
| 65862-567-30 | 6586205673065862056730 | 30 TABLET, CHEWABLE in 1 BOTTLE (65862-567-30)Marketed from Aug 3, 2012 | |
| 65862-567-90 | 6586205679065862056790 | 90 TABLET, CHEWABLE in 1 BOTTLE (65862-567-90)Marketed from Aug 3, 2012 |
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 sodium — 4 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202096
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65862-567_035c2d56-5707-4d1e-96b8-7c9c2e848bb6SPL ID 035c2d56-5707-4d1e-96b8-7c9c2e848bb6SPL set ID ba42b0a9-83f1-4283-a853-f99cdd0761b9RxCUI 200224, 242438, 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
N465862056705followed by a unit qualifier and the quantityPackage 65862-0567-05. 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 is 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 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium is indicated for the proph…
Excerpt only. Read the full label for complete information.
About NDC 65862-567
- What is NDC 65862-567?
- 65862-567 is the product NDC for Montelukast Sodium, Montelukast sodium 4 mg/1 tablet, chewable, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Montelukast Sodium.
- What is the active ingredient?
- Montelukast sodium.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Montelukast Sodium?
- 70 other product NDCs are listed under this name. See all Montelukast Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Montelukast Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Montelukast Sodium | Montelukast sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4753 | 70518-4753-00 |
| montelukast sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8617 | 68788-8617-0368788-8617-0668788-8617-09 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8610 | 68788-8610-0368788-8610-0668788-8610-09 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-100 | 16571-0100-0916571-0100-10 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-418 | 72189-0418-3072189-0418-90 |
| Montelukast Sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | DIRECT RX | 72189-223 | 72189-0223-30 |
| Montelukast Sodiummontelukast | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Amneal Pharmaceuticals LLC | 65162-771 | 65162-0771-03 |
| Montelukast Sodiummontelukast | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Amneal Pharmaceuticals LLC | 65162-772 | 65162-0772-03 |
| montelukast sodium | Montelukast 5 mg/1 | Tablet, ChewableOral | Preferred Pharmaceuticals, Inc. | 68788-7669 | 68788-7669-0168788-7669-0268788-7669-03+3 more |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | GranuleOral | Aurobindo Pharma Limited | 59651-329 | 59651-0329-30 |
Other NDCs under ANDA 202096
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 | Rising Pharma Holdings, Inc. | 57237-212 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Rising Pharma Holdings, Inc. | 57237-213 |