Prescription drug · ANDA
polymyxin b sulfate and trimethoprim sulfate NDC 70069-311
Polymyxin b sulfate 10000 [iU]/mL; Trimethoprim 1 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-311-01 | 7006903110170069031101 | 1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLEMarketed from Aug 6, 2024 |
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 sulfate
- Generic name (nonproprietary)
- polymyxin b sulfate and trimethoprim sulfate
- Active ingredients
- Polymyxin b sulfate — 10000 [iU]/mLTrimethoprim — 1 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211572
- 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 70069-311_80ad4adc-72c3-4398-a639-3d6a6ae9ec17SPL ID 80ad4adc-72c3-4398-a639-3d6a6ae9ec17SPL set ID 93d52a75-9a96-4f96-be41-9ccdcabc0933RxCUI 244967UNII 19371312D4, AN164J8Y0XUPC 0370069311011
- 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
N470069031101followed by a unit qualifier and the quantityPackage 70069-0311-01. 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, USP 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 70069-311
- What is NDC 70069-311?
- 70069-311 is the product NDC for polymyxin b sulfate and trimethoprim sulfate, Polymyxin b sulfate 10000 [iU]/mL; Trimethoprim 1 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. 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 sulfate.
- What is the active ingredient?
- Polymyxin b sulfate, Trimethoprim.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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 sulfate?
- 1 other product NDC are listed under this name. See all polymyxin b sulfate and trimethoprim sulfate 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 sulfate 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 trimethoprim sulfate | Polymyxin b sulfate 10000 [iU]/mL; Trimethoprim 1 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-4381 | 70518-4381-00 |
Other NDCs under ANDA 211572
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 sulfate | Polymyxin b sulfate 10000 [iU]/mL; Trimethoprim 1 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-4381 |