Ketotifen Fumarate
- Product NDC
- 50090-6472
- 11-digit product format
- 500906472
- Labeler code
- 50090
- Product ID
- 50090-6472_9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- NDA021996
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-09-18
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketotifen Fumarate
- Listing expiration
- 2026-12-31
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 |
|---|
| 50090-6472-0 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 50090-6472-0 | Ketotifen Fumarate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6472 | KETOTIFEN FUMARATE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20230513_1234de19-257c-422c-8706-1239381a2706.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6472-0 | 50090647200 | 1 BOTTLE, DROPPER in 1 CARTON (50090-6472-0) / 5 mL in 1 BOTTLE, DROPPER | 2023-05-10 | No | No | Current |