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NDC 59779-0330-02 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: 59779-0330-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 59779-0330 |
|---|---|
| Product ID | 59779-330_afed3c93-e95a-49e1-9e44-fc69c14d1173 |
| 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 | 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 59779-0330-02 (59779033002)
| NDC Package Code | 59779-330-02 |
|---|---|
| Billing NDC | 59779033002 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (59779-330-02) / 10 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2013-10-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 Details
Warnings
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
SPL UNCLASSIFIED SECTION
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 Alaway®*
NDC 59779-330-01
Contains the drug
Ketotifen Fumarate
Allergy
Eye Drops
KETOTIFEN FUMARATE
OPHTHALMIC SOLUTION 0.035%
ANTIHISTAMINE EYE DROPS
Works in minutes
• Original prescription strength
• For ages 3 years & older
• Relief for itchy eyes
• 60-day supply
GET UP TO
12
HOURS
ITCH RELIEF
Actual Product
Size on Side Panel
STERILE
10 mL (0.34 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(59779-330) , ANALYSIS(59779-330) , STERILIZE(59779-330) , PACK(59779-330) , LABEL(59779-330) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn AG | 482198285 | MANUFACTURE(59779-330) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(59779-330) , PACK(59779-330) | |