Ketotifen Fumarate
- Product NDC
- 71205-115
- 11-digit product format
- 712050115
- Labeler code
- 71205
- Product ID
- 71205-115_78139082-90f2-4200-bf95-8a46315597ed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2007-10-01
- Substance
- KETOTIFEN FUMARATE
- Active strength
- .35 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 | .35 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 |
|---|
| 71205-115-05 | Ketotifen Fumarate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
| 71205-115-05 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-115 | KETOTIFEN FUMARATE SOLUTION/ DROPS [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 2 package rows | 20191115_3a9e70ab-d188-488c-8c47-a2184eb4ef2c.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 |
|---|
| 71205-115-05 | 71205011505 | 1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER | 2018-09-04 | 0000-00-00 | No | No | Current |