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NDC 36800-0097-05 Eye Itch Relief 0.25 mg/mL Details
Eye Itch Relief 0.25 mg/mL
Eye Itch Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is KETOTIFEN FUMARATE.
MedlinePlus Drug Summary
Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Related Packages: 36800-0097-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 36800-0097 |
|---|---|
| Product ID | 36800-097_6ca0ed6a-4b37-44b1-97d1-7855ab238077 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Eye Itch Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ketotifen fumarate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | TOPCO ASSOCIATES LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021996 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0097-05 (36800009705)
| NDC Package Code | 36800-097-05 |
|---|---|
| Billing NDC | 36800009705 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2022-03-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |