NDC codes

FDA NDC Directory
Product NDC (as listed)63187-631Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0631Add 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
63187-631-10631870631101 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Dec 1, 2018

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
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 63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56SPL ID 38978a23-dfcb-4930-96a7-15f42fe54e56SPL set ID d1f55327-156f-44cd-b0fc-b1a938e8aa73RxCUI 244967UNII 19371312D4, E377MF8EQ8UPC 0363187631109
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

N463187063110 followed by a unit qualifier and the quantity

Package 63187-0631-10. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 064120

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 064120
ProductStrengthForm · routeLabelerProduct NDC
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-1651
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicBausch & Lomb Incorporated24208-315
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicPreferred Pharmaceuticals Inc.68788-8152
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicSportpharm LLC85766-141

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in