Ketotifen Fumarate
- Product NDC
- 62011-0379
- 11-digit product format
- 620110379
- Labeler code
- 62011
- Product ID
- 62011-0379_e52ca23d-f601-2a70-b759-bee35b4ec044
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Stategic Sourcing Services LLC
- Application
- ANDA077354
- Marketing category
- ANDA
- Marketing start
- 2019-06-18
- Marketing end
- 2022-10-17
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62011-0379-1 | 62011037901 | 1 BOTTLE, PLASTIC in 1 CARTON (62011-0379-1) > 5 mL in 1 BOTTLE, PLASTIC | 2019-06-18 | 0000-00-00 | No | No | Current |