Prescription drug · ANDA
Montelukast Sodium NDC 63187-781
Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-781-14 | 6318707811463187078114 | 14 TABLET, FILM COATED in 1 BOTTLE (63187-781-14)Marketed from Sep 4, 2018 | |
| 63187-781-30 | 6318707813063187078130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-781-30)Marketed from Nov 1, 2016 | |
| 63187-781-60 | 6318707816063187078160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-781-60)Marketed from Nov 1, 2016 | |
| 63187-781-90 | 6318707819063187078190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-781-90)Marketed from Nov 1, 2016 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202717
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63187-781_e36b33e0-a969-46fc-8a6a-c62f4ae61607SPL ID e36b33e0-a969-46fc-8a6a-c62f4ae61607SPL set ID 97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5RxCUI 200224UNII U1O3J18SFLUPC 0363187781903
- 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
N463187078114followed by a unit qualifier and the quantityPackage 63187-0781-14. 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 .
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 ( 1.3 ). 1.1 Asthma Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) M…
Excerpt only. Read the full label for complete information.
About NDC 63187-781
- What is NDC 63187-781?
- 63187-781 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 4 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?
- Proficient Rx LP, NDC labeler code 63187. 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 202717
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 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-119 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-762 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1926 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3355 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4047 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0514 |