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NDC 59779-0627-01 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 CVS Pharmacy. 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: 59779-0627-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 59779-0627 |
|---|---|
| Product ID | 59779-627_ef62c860-13cf-4f29-871c-4d3b61e8e916 |
| 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 | 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 | CVS Pharmacy |
| 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 | 2023-12-31 |
Package
Package Images
NDC 59779-0627-01 (59779062701)
| NDC Package Code | 59779-627-01 |
|---|---|
| Billing NDC | 59779062701 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (59779-627-01) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2013-11-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f06cf445-b84e-48ad-b30a-046bc8b79284 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 or comments?
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
CVS Health™ Logo Compare to the active
ingredient in Zaditor®*
NDC 59779-627-01
Original Prescription Strength
Eye Itch
Relief
KETOTIFEN FUMARATE
OPHTHALMIC SOLUTION 0.035%
Antihistamine eye drops
• Works in minutes
• 30 day supply
• For ages 3 years and older
GET UP TO
12
HOUR
RELIEF
Actual Product
Size on Side Panel
STERILE
5 mL (0.17 FL OZ)
INGREDIENTS AND APPEARANCE
| KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops |
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| Labeler - CVS Pharmacy (062312574) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | MANUFACTURE(59779-627) , ANALYSIS(59779-627) , STERILIZE(59779-627) , PACK(59779-627) , LABEL(59779-627) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn, AG | 482198285 | MANUFACTURE(59779-627) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(59779-627) , PACK(59779-627) | |
Revised: 2/2022
Document Id: ef62c860-13cf-4f29-871c-4d3b61e8e916
Set id: f06cf445-b84e-48ad-b30a-046bc8b79284
Version: 9
Effective Time: 20220210