What is NDC 61314-628?

61314-628 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 Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Polymyxin b sulfate, Trimethoprim sulfate.

Sandoz Inc, NDC labeler code 61314. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Polymyxin B Sulfate and Trimethoprim NDC 61314-628

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0628Add 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 NDC	11-digit (billing)	Package	Copy
61314-628-10	6131406281061314062810	1 BOTTLE, PLASTIC in 1 CARTON (61314-628-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Apr 16, 1998

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
Active ingredients: Polymyxin b sulfate — 10000 [USP'U]/mLTrimethoprim sulfate — 1 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064211
Marketing start: Apr 16, 1998
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Polymyxins (Chemical structure)
Identifiers: Product ID 61314-628_d1a232a2-1f79-4cf3-a185-689539b92606SPL ID d1a232a2-1f79-4cf3-a185-689539b92606SPL set ID 71900075-5288-4f4b-afe2-098436fa2173RxCUI 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

N461314062810 followed by a unit qualifier and the quantity

Package 61314-0628-10. 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 Sep 5, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 61314-628

What is NDC 61314-628?: 61314-628 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 Sandoz 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?: Sandoz Inc, NDC labeler code 61314. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Polymyxin B Sulfate and Trimethoprim NDCs
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	REMEDYREPACK INC.	70518-1735	70518-1735-00
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	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.

FDA NDC Directory listings under ANDA 064211
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	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
Polymyxin B Sulfate and Trimethoprim	Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL	SolutionOphthalmic	REMEDYREPACK INC.	70518-1735