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NDC 50090-2900-00 Ketotifen Fumarate 0.35 mg/mL Details
Ketotifen Fumarate 0.35 mg/mL
Ketotifen Fumarate is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by A-S Medication Solutions. 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: 50090-2900-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 50090-2900 |
|---|---|
| Product ID | 50090-2900_09bdc878-bfae-420b-9eae-18dd0160999f |
| Associated GPIs | 86802040102010 |
| GCN Sequence Number | 043118 |
| GCN Sequence Number Description | ketotifen fumarate DROPS 0.025 % OPHTHALMIC |
| HIC3 | Q6R |
| HIC3 Description | EYE ANTIHISTAMINES |
| GCN | 92451 |
| HICL Sequence Number | 006554 |
| HICL Sequence Number Description | KETOTIFEN FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Ketotifen Fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ketotifen Fumarate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.35 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | A-S Medication Solutions |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077958 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50090-2900-00 (50090290000)
| NDC Package Code | 50090-2900-0 |
|---|---|
| Billing NDC | 50090290000 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (50090-2900-0) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2017-03-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |