NDC 0065-1432
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 | 0065-1432_0652d5f3-8712-4c77-8378-c70ae2dd8057 |
| NDC | 0065-1432 |
| 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 | 2009-07-27 |
| 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 | 2023-12-31 |
Packaging
NDC 0065-1432-04
5 VIAL in 1 CARTON (0065-1432-04) > .7 mL in 1 VIAL
| Marketing Start Date | 2009-07-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-1432-06 [00065143206]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-07-27 |
NDC 0065-1432-05 [00065143205]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-07-27 |
NDC 0065-1432-01 [00065143201]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-07-27 |
| Marketing End Date | 2017-12-31 |
NDC 0065-1432-03 [00065143203]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-07-27 |
| Marketing End Date | 2017-12-31 |
NDC 0065-1432-02 [00065143202]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-07-27 |
| Marketing End Date | 2017-12-31 |
NDC 0065-1432-04 [00065143204]
Systane SOLUTION/ DROPS
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-07-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 400 | 4 mg/mL |
OpenFDA Data
| SPL SET ID: | a5c1c194-3db5-4f18-9cd1-97f7f84c3cff |
| 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]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYSTANE 98186374 not registered Live/Pending |
Alcon Inc. 2023-09-19 |
 SYSTANE 90138725 not registered Live/Pending |
Alcon Inc. 2020-08-26 |
 SYSTANE 85909669 4432556 Live/Registered |
Alcon Inc. 2013-04-19 |
 SYSTANE 85314277 4365194 Live/Registered |
ALCON INC. 2011-05-06 |
 SYSTANE 78144304 2799326 Live/Registered |
NOVARTIS AG 2002-07-16 |
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