Prescription drug · ANDA
Trimethoprim sulfate and Polymyxin B sulfate NDC 63187-193
Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL · Solution · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-193-10 | 63187019310 | 1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jan 1, 2019 |
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)
- Trimethoprim sulfate and Polymyxin B sulfate
- Generic name (nonproprietary)
- trimethoprim sulfate and polymyxin b sulfate
- Active ingredients
- Trimethoprim sulfate — 1 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065006
- 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 63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891SPL ID a0deddd4-f2c7-4594-ac0d-1ed4ce48b891SPL set ID 2c5579eb-ad81-415e-8dcb-9f1c94c897aeRxCUI 244967UNII E377MF8EQ8, 19371312D4
- 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
N463187019310followed by a unit qualifier and the quantityPackage 63187-0193-10. 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 Trimethoprim Sulfate and Polymyxin B Sulfate 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 influenza 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 63187-193
- What is NDC 63187-193?
- 63187-193 is the product NDC for Trimethoprim sulfate and Polymyxin B sulfate, Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL solution, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trimethoprim sulfate and Polymyxin B sulfate.
- What is the active ingredient?
- Trimethoprim sulfate, Polymyxin b sulfate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trimethoprim sulfate and Polymyxin B sulfate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.