Prescription drug · ANDA
Polymyxin B Sulfate and Trimethoprim NDC 24208-315
polymyxin b sulfate and trimethoprim sulfate · Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL · Solution/ drops · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-315-10 | 2420803151024208031510 | 1 BOTTLE, DROPPER in 1 CARTON (24208-315-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Feb 14, 1997 |
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
- Bausch & Lomb IncorporatedNDC labeler code 24208
- 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 24208-315_4732077c-74ed-5e9a-e063-6294a90a6315SPL ID 4732077c-74ed-5e9a-e063-6294a90a6315SPL set ID 87999254-1857-4d3c-817a-cb8f6a5b0cf7RxCUI 244967UNII 19371312D4, E377MF8EQ8
- 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
N424208031510followed by a unit qualifier and the quantityPackage 24208-0315-10. 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. 1 1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Excerpt only. Read the full label for complete information.
About NDC 24208-315
- What is NDC 24208-315?
- 24208-315 is the product NDC for Polymyxin B Sulfate and Trimethoprim, Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polymyxin B Sulfate and Trimethoprim (Polymyxin B Sulfate and Trimethoprim Sulfate).
- What is the active ingredient?
- Polymyxin b sulfate, Trimethoprim sulfate.
- Who is the labeler?
- Bausch & Lomb Incorporated, NDC labeler code 24208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Polymyxin B Sulfate and Trimethoprim?
- 10 other product NDCs are listed under this name. See all Polymyxin B Sulfate and Trimethoprim NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Polymyxin B Sulfate and Trimethoprim products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 68788-8152-01 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | REMEDYREPACK INC. | 70518-1735 | 70518-1735-00 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Preferred Pharmacetucials Inc. | 68788-6927 | 68788-6927-01 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-2925 | 50090-2925-00 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Sandoz Inc | 61314-628 | 61314-0628-10 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Proficient Rx LP | 63187-834 | 63187-0834-10 |
| Polymyxin B Sulfate and Trimethoprim | Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4103 | 68071-4103-05 |
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-631 | 63187-0631-10 |
| 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 | 68071-1651-05 |
| 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 | 85766-0141-10 |
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 | Proficient Rx LP | 63187-631 |
| 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 | 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 |