Ketotifen Fumarate Ophthalmic Solution
- Product NDC
- 68788-4084
- 11-digit product format
- 687884084
- Labeler code
- 68788
- Product ID
- 68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2026-02-27
- Substance
- KETOTIFEN FUMARATE
- Active strength
- .25 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketotifen Fumarate Ophthalmic Solution
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOTIFEN FUMARATE | .25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HBD503WORO |
| Rxcui | 311237 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4084-5 | Ketotifen Fumarate Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 68788-4084-5 | Ketotifen Fumarate Ophthalmic Solution | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4084-5 | 68788408405 | 1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER | 2026-02-27 | No | No | Historical |