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NDC 76385-0106-17 Ketotifen Fumarate 0.25 mg/mL Details
Ketotifen Fumarate 0.25 mg/mL
Ketotifen Fumarate is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bayshore Pharmaceuticals, 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: 76385-0106-17Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 76385-0106 |
|---|---|
| Product ID | 76385-106_ca50459a-8472-4a04-bae3-51f27113c37d |
| 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 |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | Bayshore Pharmaceuticals, LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204059 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 76385-0106-17 (76385010617)
| NDC Package Code | 76385-106-17 |
|---|---|
| Billing NDC | 76385010617 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.28248 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | KETOTIFEN FUM 0.035% EYE DROPS |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 0fe119ad-cb44-4e90-a096-0ed0ba63dc31 Details
Warnings
For external use only
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
When using this product
- do not touch tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lenses after use
- replace cap after each use
Directions
Other information
Inactive ingredients
Questions?
Principal Display Panel - Bottle Label
Principal Display Panel - Bottle Carton
INGREDIENTS AND APPEARANCE
| KETOTIFEN FUMARATE
ketotifen fumarate solution |
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| Labeler - Bayshore Pharmaceuticals, LLC (968737416) |
Revised: 10/2021
Document Id: ca50459a-8472-4a04-bae3-51f27113c37d
Set id: 0fe119ad-cb44-4e90-a096-0ed0ba63dc31
Version: 1
Effective Time: 20211015