Prescription drug · ANDA
Polymyxin B Sulfate and Trimethoprim NDC 63187-834
Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL · Solution · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-834-10 | 63187083410 | 10 mL in 1 BOTTLE, PLASTIC (63187-834-10)Marketed 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
- Active ingredients
- Polymyxin b sulfate — 10000 [USP'U]/mLTrimethoprim sulfate — 1 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064211
- 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 63187-834_0ccbd919-79d8-4159-9b3e-c31230c157dbSPL ID 0ccbd919-79d8-4159-9b3e-c31230c157dbSPL set ID 1252b997-3a81-4f3c-90e4-92f29ba15713RxCUI 244967UNII 19371312D4, E377MF8EQ8UPC 0363187834104
- 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
N463187083410followed by a unit qualifier and the quantityPackage 63187-0834-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064211
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 Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | REMEDYREPACK INC. | 70518-1735 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Sandoz Inc | 61314-628 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-2925 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Preferred Pharmacetucials Inc. | 68788-6927 |
| Polymyxin B Sulfate and Trimethoprim | Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4103 |