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 | 0006514310100065143101 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-05 | 0006514310500065143105 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-18 | 0006514311800065143118 | 3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-21 | 0006514312100065143121 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-28 | 0006514312800065143128 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-31 | 0006514313100065143131 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-41 | 0006514314100065143141 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2014 | |
| 0065-1431-80 | 0006514318000065143180 | 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 |
|---|---|---|---|---|
| Walgreens Eye Drops Maximum Redness Relief 15mLglycerin, naphazoline hci | Naphazoline hydrochloride .03 g/100mL; Glycerin .5 g/100mL | Solution/ dropsOphthalmic | Walgreen Company | 0363-4546 |
| Vista Gonio Eye Lubricanthypromellose ophthalmic solution | Hypromellose 2208 (100 mpa.s) 25 mg/15mL | SolutionOphthalmic | Red Wedding LLC | 77790-022 |
| Capasil Pain Relievingmenthol, methyl salicylate | Methyl salicylate 100 mg/mL; Menthol 20 mg/mL | CreamTopical | PureTek Corporation | 59088-434 |
| Rugby Eye Washwater, purified | Water 99.05 g/100mL | SolutionOphthalmic | A-S Medication Solutions | 50090-7440 |
| DG Original Eye Dropstetrahydrozoline hcl | Tetrahydrozoline hydrochloride .05 g/100mL | SolutionOphthalmic | Dolgencorp LLC | 55910-363 |
| TopCare Health Lubricant Eye Dropscarboxymethylcellulose sodium | Carboxymethylcellulose sodium .5 g/100mL | Solution/ dropsOphthalmic | Topcare Associates LLC | 76162-089 |
| VitaPhyte Lubricating Eye Dropslubricating eye drops | Carboxymethylcellulose sodium 5 mg/mL; Glycerin 3 mg/mL | SolutionOphthalmic | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 87770-008 |
| VISTA Hypromellose Dry Eye Reliefhypromellose | Hypromellose 2910 (50 mpa.s) .3 g/mL | GelOphthalmic | Red Wedding LLC | 77790-002 |
| EyS Eye Washwater | Water 14.85 mL/15mL | SolutionOphthalmic | Eyes-Plus LLC | 57349-220 |
| DG Health Advanced Relief Eye Dropsdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl | Povidone, Unspecified 1 g/100mL + 3 more ingredients | SolutionOphthalmic | Dolgencorp LLC | 55910-361 |
| Fendall 2000 Pure Flowpurified water | Water 98.6 L/100L | LiquidOphthalmic | Honeywell Safety Products USA, Inc. | 0498-0631 |
| VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlpropylene glycol | Propylene glycol .6 g/100mL | LiquidOphthalmic | Red Wedding LLC | 77790-003 |
| VitaPhyte Lubricant Eye Dropslubricant eye drops | Carboxymethylcellulose sodium 5 mg/mL; Glycerin 3 mg/mL | SolutionOphthalmic | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 87770-020 |
| DG Health Dry Eye Reliefglycerin, hypromellose, polypropylene glycol 400 | Polyethylene glycol 400 1 g/100mL + 2 more ingredients | SolutionOphthalmic | Dolgencorp LLC | 55910-362 |
| Optaseglycerin | Glycerin 2 mg/mL | Solution/ dropsOphthalmic | Scope Health Inc | 72972-002 |
| Rippleglycerin, povidone | Glycerin .63 g/100mL; Povidone .25 g/100mL | Solution/ dropsOphthalmic | CorneaCare Inc | 82875-003 |
| Salinenasal | Sodium chloride 6.5 mg/mL | SprayNasal | GERI-CARE PHARMACEUTICAL CORP | 57896-333 |
| Signature Care Lubricant Eye Dropscarboxymethylcellulose sodium | Carboxymethylcellulose sodium .5 g/100mL | Solution/ dropsOphthalmic | Better Living Brands LLC | 21130-705 |
| Optaseglycerin | Glycerin 1 mg/mL | SprayOphthalmic | Scope Health Inc | 72972-001 |
| Discount Drug Mart Eye Drops Multi-Symptom Reliefpolyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate | Zinc sulfate .25 g/100mL + 2 more ingredients | Solution/ dropsOphthalmic | Discount Drug Mart, Inc. | 53943-490 |
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