NDC 0065-1431
Systane Ultra
Polyethylene Glycol 400 And Propylene Glycol
Systane Ultra is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Polyethylene Glycol 400; Propylene Glycol.
| Product ID | 0065-1431_22a90eb2-bae4-4c23-a66b-814ae1196dc8 |
| NDC | 0065-1431 |
| Product Type | Human Otc Drug |
| Proprietary Name | Systane Ultra |
| Generic Name | Polyethylene Glycol 400 And Propylene Glycol |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2014-10-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part349 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL |
| Active Ingredient Strength | 4 mg/mL; mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0065-1431-01
1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) > 1.5 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2014-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-1431-01 [00065143101]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-88 [00065143188]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-03-01 |
| Marketing End Date | 2017-09-11 |
NDC 0065-1431-21 [00065143121]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-05 [00065143105]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-11-30 |
NDC 0065-1431-80 [00065143180]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-41 [00065143141]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-18 [00065143118]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-31 [00065143131]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-10-01 |
NDC 0065-1431-28 [00065143128]
Systane Ultra SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-10-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 400 | 4 mg/mL |
OpenFDA Data
| SPL SET ID: | 1f3a65f4-1a76-5a1d-5169-1029ad00df1f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Systane Ultra" or generic name "Polyethylene Glycol 400 And Propylene Glycol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-1431 | Systane Ultra | Polyethylene Glycol 400 and Propylene Glycol |
| 0065-8067 | GenTeal Tears Gel Drops | polyethylene glycol 400 and propylene glycol |
| 11673-522 | Lubricant drops | Polyethylene Glycol 400 and Propylene Glycol |
| 0363-0307 | Lubricant Eye | Polyethylene Glycol 400 and Propylene Glycol |
| 0363-6451 | Lubricant Eye | Polyethylene Glycol 400 and Propylene Glycol |
| 11822-2701 | lubricant eye | Polyethylene Glycol 400 and Propylene Glycol |
| 30142-327 | lubricating relief | Polyethylene Glycol 400 and Propylene Glycol |
| 46122-199 | PEG-Phen Lubricant Eye Drops | Polyethylene Glycol 400 and Propylene Glycol |
| 46122-201 | PEG-Phen Ultra Lubricant Eye Drops | Polyethylene Glycol 400 and Propylene Glycol |
| 11822-4540 | RITE AID lubricant drops | polyethylene glycol 400 and propylene glycol |
| 0065-0454 | Systane | polyethylene glycol 400 and propylene glycol |
| 0065-1432 | Systane | polyethylene glycol 400 and propylene glycol |
| 0065-1437 | SYSTANE HYDRATION PF PRESERVATIVE FREE | Polyethylene Glycol 400 and Propylene Glycol |
| 0065-1510 | SYSTANE HYDRATION PF PRESERVATIVE FREE | Polyethylene Glycol 400 and Propylene Glycol |
| 0065-0429 | Systane Lubricant | polyethylene glycol 400 and Propylene Glycol |
| 0065-1507 | Systane Ultra Preservative Free | Polyethylene Glycol 400 and Propylene Glycol |
| 0363-7267 | Walgreens Lubricant Eye | Polyethylene Glycol 400 and Propylene Glycol |
Trademark Results [Systane Ultra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYSTANE ULTRA 77319393 3457632 Live/Registered |
NOVARTIS AG 2007-11-01 |
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