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NDC 00065-1431-01 Systane Ultra 4; 3 mg/mL; mg/mL Details
Systane Ultra 4; 3 mg/mL; mg/mL
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 Information
| NDC | 00065-1431 |
|---|---|
| Product ID | 0065-1431_e552d401-ec86-4cab-a8c7-1dc28068d26e |
| Associated GPIs | 86209902482020 |
| GCN Sequence Number | 052162 |
| GCN Sequence Number Description | propylene glycol/peg 400 DROPS 0.3 %-0.4% OPHTHALMIC |
| HIC3 | Q6T |
| HIC3 Description | ARTIFICIAL TEARS |
| GCN | 19719 |
| HICL Sequence Number | 025225 |
| HICL Sequence Number Description | PROPYLENE GLYCOL/POLYETHYLENE GLYCOL 400 |
| Brand/Generic | Brand |
| Proprietary Name | Systane Ultra |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Polyethylene Glycol 400 and Propylene Glycol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 4; 3 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL |
| Labeler Name | Alcon Laboratories, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M018 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00065-1431-01 (00065143101)
| NDC Package Code | 0065-1431-01 |
|---|---|
| Billing NDC | 00065143101 |
| Package | 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 |
| Pricing Information | N/A |