Prescription drug · ANDA
Montelukast NDC 68001-361
Montelukast sodium 10 mg/1 · Tablet · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-361-03 | 6800103610368001036103 | 500 TABLET in 1 BOTTLE (68001-361-03)Marketed from Jun 29, 2018 | |
| 68001-361-04 | 6800103610468001036104 | 30 TABLET in 1 BOTTLE (68001-361-04)Marketed from Jun 29, 2018 | |
| 68001-361-05 | 6800103610568001036105 | 90 TABLET in 1 BOTTLE (68001-361-05)Marketed from Jun 29, 2018 |
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
- Generic name (nonproprietary)
- montelukast
- Active ingredients
- Montelukast sodium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203366
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68001-361_d9dbbe03-bcc4-1af7-e053-2a95a90a8053SPL ID d9dbbe03-bcc4-1af7-e053-2a95a90a8053SPL set ID 4c411d3e-47b6-481b-b846-419ed4cbb947RxCUI 200224UNII U1O3J18SFLUPC 0368001361040, 0368001361033, 0368001361057
- 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
N468001036103followed by a unit qualifier and the quantityPackage 68001-0361-03. 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 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 i…
Excerpt only. Read the full label for complete information.
About NDC 68001-361
- What is NDC 68001-361?
- 68001-361 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Montelukast.
- What is the active ingredient?
- Montelukast sodium.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. 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?
- 15 other product NDCs are listed under this name. See all Montelukast NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Montelukast 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 | Montelukast sodium 10 mg/1 | TabletOral | Coupler LLC | 67046-2060 | 67046-2060-03 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-009 | 82009-0009-10 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-556 | 50268-0556-15 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8099 | 68788-8099-0368788-8099-0668788-8099-09 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3133 | 70518-3133-0070518-3133-0170518-3133-02 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-563 | 71610-0563-30 |
| Montelukast | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-175 | 72865-0175-1072865-0175-3072865-0175-90 |
| Montelukast | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 63187-626 | 63187-0626-3063187-0626-6063187-0626-90 |
| Montelukast | Montelukast sodium 10 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-102 | 33342-0102-0733342-0102-1033342-0102-12+2 more |
| Montelukast | Montelukast sodium 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3855 | 68071-3855-03 |
Other NDCs under ANDA 203366
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 | TabletOral | Macleods Pharmaceuticals Limited | 33342-102 |
| Montelukast | Montelukast sodium 10 mg/1 | TabletOral | Coupler LLC | 67046-2060 |
| Montelukast | Montelukast sodium 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3855 |
| Montelukast | Montelukast sodium 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4034 |