KETOTIFEN FUMARATE
- Product NDC
- 76385-106
- 11-digit product format
- 763850106
- Labeler code
- 76385
- Product ID
- 76385-106_948d4259-9d62-4bc7-9149-6961034364bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- KETOTIFEN FUMARATE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA204059
- Marketing category
- ANDA
- Marketing start
- 2021-10-15
- 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 |
|---|
| 76385-106-17 | KETOTIFEN FUMARATE | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 2 |
| 76385-106-17 | KETOTIFEN FUMARATE | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76385-106 | KETOTIFEN FUMARATE SOLUTION [BAYSHORE PHARMACEUTICALS, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211023_0fe119ad-cb44-4e90-a096-0ed0ba63dc31.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76385-106-17 | 76385010617 | 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC | 2021-10-15 | 0000-00-00 | No | No | Current |