NDC 0065-4011 – Zaditor
Ketotifen Fumarate .25 mg/mL · Solution · Ophthalmic
Product NDC0065-4011
Product details
- Brand name
- Zaditor
- Generic name
- Ketotifen fumarate
- Labeler
- Alcon Laboratories, Inc.
- Dosage form
- Solution
- Route
- Ophthalmic
- Marketing category
- ANDA · ANDA077200
- Marketed since
- January 8, 2013
- Listing expires
- December 31, 2026
- Pharmacologic class
- Histamine-1 Receptor Inhibitor
Active ingredients
- Ketotifen Fumarate .25 mg/mL
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0065-4011-05 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER | Mar 13, 2013 |
| 0065-4011-06 | 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER | Jan 8, 2013 |
| 0065-4011-11 | 3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER | Feb 13, 2015 |
Recalls mentioning this NDC
- D-1317-2022 Aug 17, 2022 · Class II
CGMP Deviations: products were stored outside the drug label specifications.