Ketotifen Fumarate
- Product NDC
- 68788-8715
- 11-digit product format
- 687888715
- Labeler code
- 68788
- Product ID
- 68788-8715_45477f1c-fa33-4ecc-b608-67280f68385a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204059
- Marketing category
- ANDA
- Marketing start
- 2024-07-12
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| HBD503WORO | KETOTIFEN FUMARATE | 34580-14-8 | KETOTIFEN FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8715-5 | 68788871505 | 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC | 2024-07-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Preferred Pharmaceuticals Inc. | 2026-05-15 | HUMAN OTC DRUG LABEL | 3 |