Prescription drug · ANDA
Polymyxin B Sulfate and Trimethoprim NDC 70518-1735
Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL · Solution · Ophthalmic · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1735-0 | 7051817350070518173500 | 10 mL in 1 BOTTLE, PLASTIC (70518-1735-0)Marketed from Dec 14, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-1735_49626196-7f03-d41b-e063-6294a90a3bfcSPL ID 49626196-7f03-d41b-e063-6294a90a3bfcSPL set ID 2a040ba4-54bd-41e4-b519-01ca6a59658fRxCUI 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
N470518173500followed by a unit qualifier and the quantityPackage 70518-1735-00. 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.
About NDC 70518-1735
- What is NDC 70518-1735?
- 70518-1735 is the product NDC for Polymyxin B Sulfate and Trimethoprim, Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL solution, listed with the FDA by REMEDYREPACK INC.. 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.
- What is the active ingredient?
- Polymyxin b sulfate, Trimethoprim sulfate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | 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 | Bausch & Lomb Incorporated | 24208-315 | 24208-0315-10 |
| Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfate | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | Solution/ dropsOphthalmic | 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 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 | A-S Medication Solutions | 50090-2925 |
| 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 | Proficient Rx LP | 63187-834 |
| Polymyxin B Sulfate and Trimethoprim | Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4103 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Preferred Pharmacetucials Inc. | 68788-6927 |