Over-the-counter drug · OTC MONOGRAPH DRUG
Systane Ultra NDC 0065-1431
polyethylene glycol 400 and propylene glycol · Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL · Solution/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0065-1431Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00065-1431Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-1431-01 | 00065143101 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-05 | 00065143105 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-18 | 00065143118 | 3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-21 | 00065143121 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-28 | 00065143128 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-31 | 00065143131 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-41 | 00065143141 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-80 | 00065143180 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Systane Ultra
- Generic name (nonproprietary)
- polyethylene glycol 400 and propylene glycol
- Active ingredients
- Polyethylene glycol 400 — 4 mg/mLPropylene glycol — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.NDC labeler code 0065
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 018
- Marketing start
- Listing expires
- Identifiers
- Product ID 0065-1431_85a171a8-6208-4d82-8e8f-472b6c480866SPL ID 85a171a8-6208-4d82-8e8f-472b6c480866SPL set ID 0537c23a-15f7-be64-1231-a6c93468e9a8RxCUI 477589UNII B697894SGQ, 6DC9Q167V3UPC 0300651431056
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
N400065143101followed by a unit qualifier and the quantityPackage 00065-1431-01. 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)
Uses for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
Excerpt only. Read the full label for complete information.
About NDC 0065-1431
- What is NDC 0065-1431?
- 0065-1431 is the product NDC for Systane Ultra, Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL solution/ drops, listed with the FDA by Alcon Laboratories, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Systane Ultra (Polyethylene Glycol 400 and Propylene Glycol).
- What is the active ingredient?
- Polyethylene glycol 400, Propylene glycol.
- Who is the labeler?
- Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Systane Ultra?
- 1 other product NDC are listed under this name. See all Systane Ultra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Systane Ultra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Systane ULTRApolyethylene glycol 400 and propylene glycol | Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0065-1432 | 00065-1432-0400065-1432-0500065-1432-06 |
Other NDCs under M 018
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 |
|---|---|---|---|---|
| Refresh P.M.mineral oil, petrolatum | Mineral oil 425 mg/g; Petrolatum 573 mg/g | OintmentOphthalmic | Allergan, Inc. | 0023-0240 |
| Walgreens Soothing Eye Relief Lubricant Eye Dropspolyvinyl alcohol, povidone | Polyvinyl alcohol .5 g/100mL; Povidone .6 g/100mL | Solution/ dropsOphthalmic | Walgreens Co. | 0363-0796 |
| Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLglycerin ophthalmic solution | Glycerin 5 mg/mL | Solution/ dropsOphthalmic | M & M PRODUCTS, L.L.C. | 87354-002 |
| Colirio Oftal-Mycinglycerin, naphazoline hydrochloride | Glycerin .25 g/100mL; Naphazoline hydrochloride .012 g/100mL | Solution/ dropsOphthalmic | Grandall Distributing Co., Inc. | 48201-107 |
| Meijer Lubricant Eye Dropspolyethylene glycol 400, propylene glycol | Propylene glycol .3 g/100mL; Polyethylene glycol 400 .4 g/100mL | Solution/ dropsOphthalmic | Meijer Distribution, Inc. | 41250-319 |
| Systane Ultra Preservative Freepolyethylene glycol 400 and propylene glycol | Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0065-1507 |
| Regener-Eyes Ophthalmic Solution LITE XLglycerin ophthalmic solution | Glycerin 4 mg/mL | Solution/ dropsOphthalmic | M & M PRODUCTS, L.L.C. | 87354-001 |
| Polyvinyl Alcohol | Polyvinyl alcohol 14 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7119 |
| Winco Maximum Redness Relief Eye Dropsglycerin, naphazoline hcl | Glycerin 500 mg/100mL; Naphazoline hydrochloride 30 mg/100mL | Solution/ dropsOphthalmic | WinCo Foods, LLC | 67091-285 |
| Publix Advanced Relief Eye Dropsdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride | Dextran 70 .1 g/100mL + 3 more ingredients | Solution/ dropsOphthalmic | Publix Super Markets, Inc. | 56062-084 |
| Meijer Redness Reliefglycerin, naphazoline hci | Naphazoline hydrochloride .012 g/100mL; Glycerin .25 g/100mL | Solution/ dropsOphthalmic | Meijer Distribution, Inc. | 41250-846 |
| Equate Lubricant Eye Dropspolyethylene glycol 400, propylene glycol | Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL | Solution/ dropsOphthalmic | Walmart, Inc. | 79903-131 |
| Artificial Tears Lubricant Eye Dropsglycerin, propylene glycol | Glycerin 3 mg/mL; Propylene glycol 10 mg/mL | Solution/ dropsOphthalmic | CVS Pharmacy | 69842-454 |
| Meijer Lubricant Eye Dropscarboxymethylcellulose sodium | Carboxymethylcellulose sodium .5 g/100mL | Solution/ dropsOphthalmic | Meijer Distribution, Inc. | 79481-0066 |
| Systane Hydration PF Preservative Freepolyethylene glycol 400 and propylene glycol | Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0065-1510 |
| REFRESH OPTIVE Advancedcarboxymethylcellulose sodium, glycerin, and polysorbate 80 | Carboxymethylcellulose sodium 5 mg/mL + 2 more ingredients | Solution/ dropsOphthalmic | Allergan, Inc. | 0023-4307 |
| Exchange Select Maximum Redness Relief Eye Dropsglycerin, naphazoline hcl | Glycerin .5 g/100mL; Naphazoline hydrochloride .03 g/100mL | Solution/ dropsOphthalmic | Army and Air Force Exchange Service | 55301-998 |
| Tyson 2.0 Mike Red Eye Drops For Dry High Eyesglycerin, naphazoline hcl | Glycerin .5 g/100mL; Naphazoline hydrochloride .03 g/100mL | Solution/ dropsOphthalmic | Jbrands Pharma L.L.C. | 84843-0050 |
| Sunmark Eye Drops Advanced Moisturizer/Lubricantdextran, polyethylene glycol 400, povidone, tetrahydrozoline | Dextran 70 .1 g/100mL + 3 more ingredients | Solution/ dropsOphthalmic | Strategic Sourcing Services LLC | 49348-697 |
| Discount Drug Mart Eye Drops A.C.tetrahydrozoline hcl, zinc sulfate | Tetrahydrozoline hydrochloride .05 g/100mL; Zinc sulfate .25 g/100mL | SolutionOphthalmic | Discount Drug Mart | 53943-062 |
Showing 20 of 40.