Over-the-counter drug · OTC MONOGRAPH DRUG
Systane (Polyethylene glycol and propylene glycol) NDC 0065-0431
Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL · Solution/ drops · Ophthalmic · Alcon Research Ltd
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0065-0431Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00065-0431Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0431-33 | 0006504313300065043133 | 30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIALMarketed from Oct 30, 2015 |
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
- Generic name (nonproprietary)
- polyethylene glycol and propylene glycol
- Active ingredients
- Polyethylene glycol 400 — 4 mg/mLPropylene glycol — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Research LtdNDC labeler code 0065
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 018
- Marketing start
- Listing expires
- Identifiers
- Product ID 0065-0431_5c7432b0-b4b8-49a1-89b7-6e3befa25917SPL ID 5c7432b0-b4b8-49a1-89b7-6e3befa25917SPL set ID 14916d2c-a63d-491e-bd91-a61f300af38aRxCUI 477589UNII B697894SGQ, 6DC9Q167V3
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
N400065043133followed by a unit qualifier and the quantityPackage 00065-0431-33. 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
Excerpt only. Read the full label for complete information.
About NDC 0065-0431
- What is NDC 0065-0431?
- 0065-0431 is the product NDC for Systane, Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL solution/ drops, listed with the FDA by Alcon Research Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Systane (Polyethylene glycol and propylene glycol).
- What is the active ingredient?
- Polyethylene glycol 400, Propylene glycol.
- Who is the labeler?
- Alcon Research Ltd, 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?
- 2 other product NDCs are listed under this name. See all Systane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Systane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Systanehypromellose | Hypromellose 2910 (4000 mpa.s) 3 mg/g | GelOphthalmic | Alcon Laboratories, Inc. | 0065-0474 | 00065-0474-01 |
| Systanepolyethylene glycol 400 and propylene glycol | Polyethylene glycol 400 4 mg/mL; Propylene glycol 3 mg/mL | GelOphthalmic | Alcon Laboratories, Inc. | 0065-0454 | 00065-0454-07 |
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 |
|---|---|---|---|---|
| Eyewash Additive Concentratewater and propylene glycol | Water 2374.4 L/2800L; Propylene glycol 280 kg/2800L | LiquidOphthalmic | Haws Corporation | 66051-236 |
| Signature Care Lubricant Eye Drops Long Lastingpolyethylene glycol 400, propylene glycol | Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL | SolutionOphthalmic | Better Living Brands, LLC | 21130-756 |
| Polyvinyl Alcohol | Polyvinyl alcohol 14 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7119 |
| 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 |
| Sodium Chloride | Sodium chloride 1000 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-361 |
| VitaPhyte Redness Reliever Lubricant Eye Dropsredness reliever lubricant eye drops | Tetrahydrozoline 5 mg/100g; Polyethylene glycol 400 1 g/100g | SolutionOphthalmic | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 87770-001 |
| Signature Care Lubricant Eye Dropscarboxymethylcellulose sodium | Carboxymethylcellulose sodium .5 g/100mL | Solution/ dropsOphthalmic | Better Living Brands LLC | 21130-705 |
| Droptics Performance Eye Dropsnaphazoline hydrochloride, propylene glycol | Naphazoline hydrochloride .03 g/100mL; Propylene glycol 1 g/100mL | LiquidOphthalmic | Droptics LLC | 85211-001 |
| Signature Care Eye Drops High Performancepolyethylene glycol 400, propylene glycol | Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL | Solution/ dropsOphthalmic | Better Living Brands LLC | 21130-702 |
| Droptics Dry Eye Reliefcarboxymethylcellulose sodium,glycerin,polysorbate 80 | Carboxymethylcellulose sodium .5 g/100mL + 2 more ingredients | LiquidOphthalmic | Droptics LLC | 85211-002 |
| Gentle Eyes Lubricant Eye Dropscarboxymethylcellulose sodium | Carboxymethylcellulose sodium 5 mg/mL | Solution/ dropsOphthalmic | TRP Company | 17312-430 |
| Signature Care Eye Drops Redness and Dry Eye Reliefglycerin, naphazoline hydrochloride | Glycerin .25 g/100mL; Naphazoline hydrochloride .012 g/100mL | Solution/ dropsOphthalmic | Better Living Brands LLC | 21130-703 |
| Signature Care Eye Drops Advanced Reliefdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl | Dextran 70 100 mg/100mL + 3 more ingredients | Solution/ dropsOphthalmic | Better Living Brands LLC | 21130-704 |
| REFRESH Optive Mega-3carboxymethylcellulose sodium, glycerin and polysorbate 80 | Carboxymethylcellulose sodium 5 mg/mL + 2 more ingredients | Solution/ dropsOphthalmic | Allergan, Inc. | 0023-4230 |
| Sodium Chloride | Sodium chloride 1 g/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-119 |
| CVS Lubricant Eye Drops Originalpolyethylene glycol 400, propylene glycol | Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL | SolutionOphthalmic | CVS | 69842-746 |
| Sodium Chloride Normal Saltsodium chloride | Sodium chloride 1 g/1 | TabletOral | Method Pharmaceuticals | 58657-118 |
| Best Choice Eye Drops Advanced Reliefdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride | Dextran 70 .1 g/100mL + 3 more ingredients | Solution/ dropsOphthalmic | Valu Merchandisers, Co. | 63941-942 |
| Meijer Multi-Symptom Reliefpolyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate | Tetrahydrozoline hydrochloride .05 g/100mL + 2 more ingredients | Solution/ dropsOphthalmic | Meijer, Inc. | 79481-0250 |
| iVIZIA Dry Eyepovidone | Povidone 25 mg/5mL | Solution/ dropsOphthalmic | Thea Pharma Inc. | 82584-700 |
Showing 20 of 40.