Prescription drug · ANDA
Montelukast Sodium (Montelukast) NDC 65162-772
Montelukast sodium 5 mg/1 · Tablet, Chewable · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-772-03 | 6516207720365162077203 | 30 TABLET, CHEWABLE in 1 BOTTLE (65162-772-03)Marketed from Sep 4, 2020 |
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
- Active ingredients
- Montelukast sodium — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205107
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-772_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909cSPL ID ed8a8093-3cde-44cf-9bdc-c8bc5fb9909cSPL set ID bcd49102-a21c-4628-a322-6cdd934e7f09RxCUI 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
N465162077203followed by a unit qualifier and the quantityPackage 65162-0772-03. 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) Limitations of Use: Not indicated to treat an acute asthma attack. (5.2) 1.1 Asthma Montelukast sodium chewable tablets …
Excerpt only. Read the full label for complete information.
About NDC 65162-772
- What is NDC 65162-772?
- 65162-772 is the product NDC for Montelukast Sodium (montelukast), Montelukast sodium 5 mg/1 tablet, chewable, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Montelukast Sodium (Montelukast).
- What is the active ingredient?
- Montelukast sodium.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 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 |
| montelukast sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Unichem Pharmaceuticals (USA), Inc. | 29300-221 | 29300-0221-1029300-0221-1329300-0221-19 |
Other NDCs under ANDA 205107
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 Sodiummontelukast | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Amneal Pharmaceuticals LLC | 65162-771 |