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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketotifen Fumarate
- 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 |
|---|
| 68788-8715-5 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 68788-8715-5 | Ketotifen Fumarate | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8715 | KETOTIFEN FUMARATE SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20240727_5196ec5b-42d9-40db-a77a-c00360b8cee6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |