Prescription drug · ANDA
Polymyxin B Sulfate and Trimethoprim NDC 63187-631
polymyxin b sulfate and trimethoprim sulfate · Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL · Solution/ drops · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-631-10 | 63187063110 | 1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Dec 1, 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)
- Polymyxin B Sulfate and Trimethoprim
- Generic name (nonproprietary)
- polymyxin b sulfate and trimethoprim sulfate
- Active ingredients
- Polymyxin b sulfate — 10000 [USP'U]/mLTrimethoprim sulfate — 1 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064120
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56SPL ID 38978a23-dfcb-4930-96a7-15f42fe54e56SPL set ID d1f55327-156f-44cd-b0fc-b1a938e8aa73RxCUI 244967UNII 19371312D4, E377MF8EQ8UPC 0363187631109
- Pharmacologic class
- Dihydrofolate Reductase Inhibitor Antibacterial; Polymyxin-class Antibacterial
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463187063110followed by a unit qualifier and the quantityPackage 63187-0631-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 064120
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 |
|---|---|---|---|---|
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-1651 |
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-315 |
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8152 |
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-141 |