NDC codes

FDA NDC Directory
Product NDC (as listed)63187-193Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0193Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63187-193-10631870193101 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

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

N463187019310 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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