FreshKote Preservative Free Lubricant Eye Drops
- Product NDC
- 71776-001
- 11-digit product format
- 717760001
- Labeler code
- 71776
- Product ID
- 71776-001_4ef5ad57-d826-8962-e063-6294a90a401a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone, Polyvinyl Alcohol
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Eyevance Pharmaceuticals
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-13
- Substance
- POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE
- Active strength
- 27; 20 g/1000mL; g/1000mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FreshKote Preservative Free Lubricant Eye Drops
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYVINYL ALCOHOL, UNSPECIFIED | 27 g/1000mL |
| POVIDONE | 20 g/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 532B59J990, FZ989GH94E |
| Rxcui | 630977, 630981 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71776-001-03 | FreshKote Preservative Free Lubricant Eye Drops | 30 in 1 BOX | SOLUTION | 30 | | 6 |
| 71776-001-03 | FreshKote Preservative Free Lubricant Eye Drops | 0.3 mL in 1 VIAL, SINGLE-USE | SOLUTION | 0.3 | | 6 |
| 71776-001-10 | FreshKote Preservative Free Lubricant Eye Drops | 1 in 1 BOX | SOLUTION | 1 | | 6 |
| 71776-001-10 | FreshKote Preservative Free Lubricant Eye Drops | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71776-001 | FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [EYEVANCE PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231006_f51c50c3-43ae-4169-9d2b-22b239461dd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71776-001-03 | 71776000103 | 30 VIAL, SINGLE-USE in 1 BOX (71776-001-03) / .3 mL in 1 VIAL, SINGLE-USE | 2020-12-06 | 0000-00-00 | No | No | Current |
| 71776-001-10 | 71776000110 | 1 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPER | 2019-03-13 | 0000-00-00 | No | No | Current |