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NDC 00065-1437-05 SYSTANE HYDRATION PF PRESERVATIVE FREE 4; 3 mg/mL; mg/mL Details
SYSTANE HYDRATION PF PRESERVATIVE FREE 4; 3 mg/mL; mg/mL
SYSTANE HYDRATION PF PRESERVATIVE FREE 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 | 00065-1437 |
|---|---|
| Product ID | 0065-1437_1eb226c4-8b11-4a92-ab95-5333e866ba13 |
| Associated GPIs | 86209902482022 |
| GCN Sequence Number | 058288 |
| GCN Sequence Number Description | propylene glycol/peg 400/PF DROPERETTE 0.3 %-0.4% OPHTHALMIC |
| HIC3 | Q6T |
| HIC3 Description | ARTIFICIAL TEARS |
| GCN | 23696 |
| HICL Sequence Number | 038529 |
| HICL Sequence Number Description | PROPYLENE GLYCOL/POLYETHYLENE GLYCOL 400/PF |
| Brand/Generic | Brand |
| Proprietary Name | SYSTANE HYDRATION PF PRESERVATIVE FREE |
| 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 00065-1437-05 (00065143705)
| NDC Package Code | 0065-1437-05 |
|---|---|
| Billing NDC | 00065143705 |
| Package | 5 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-05) / .7 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |