EYE ITCH RELIEF
- Product NDC
- 0363-0610
- 11-digit product format
- 003630610
- Labeler code
- 0363
- Product ID
- 0363-0610_d186b442-7413-4447-b3f1-c3c82fb4e258
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Walgreens
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- Marketing end
- 0000-00-00
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0610-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-22ef-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0610-10 | EYE ITCH RELIEF | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 3 | |
| 0363-0610-10 | EYE ITCH RELIEF | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | ACTIVE INGREDIENT | HBD503WORO | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| KETOTIFEN | ACTIVE MOIETY | X49220T18G | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd | 3 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd | 3 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd | 3 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd | 3 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 0363-0610-10 | 00363061010 | 5 mL in 1 BOTTLE, DROPPER | 5 ml | Historical |