Prescription drug · ANDA
Montelukast Sodium NDC 43063-381
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-381-21 | 43063038121 | 21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21)Marketed from Nov 5, 2015 | |
| 43063-381-30 | 43063038130 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)Marketed from Nov 5, 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 sodium — 4 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090984
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43063-381_5c189caa-a616-fc04-e063-6394a90a27dcSPL ID 5c189caa-a616-fc04-e063-6394a90a27dc
- 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
N443063038121followed by a unit qualifier and the quantityPackage 43063-0381-21. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 090984
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 | Proficient Rx LP | 63187-550 |
| Montelukast Sodium | Montelukast sodium 4 mg/1 | Tablet, ChewableOral | Torrent Pharmaceuticals Limited | 13668-079 |
| Montelukast Sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Torrent Pharmaceuticals Limited | 13668-080 |