| Product NDC: | 50580-732 |
| Proprietary Name: | Zyrtec |
| Non Proprietary Name: | Ketotifen fumarate |
| Active Ingredient(s): | .345 mg/mL & nbsp; Ketotifen fumarate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50580-732 |
| Labeler Name: | McNeil Consumer Healthcare Division of McNeil-PPC, Inc. |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA077354 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090701 |
| Package NDC: | 50580-732-05 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-732-05) > 5 mL in 1 BOTTLE, PLASTIC |
| NDC Code | 50580-732-05 |
| Proprietary Name | Zyrtec |
| Package Description | 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-732-05) > 5 mL in 1 BOTTLE, PLASTIC |
| Product NDC | 50580-732 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Ketotifen fumarate |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20090701 |
| Marketing Category Name | ANDA |
| Labeler Name | McNeil Consumer Healthcare Division of McNeil-PPC, Inc. |
| Substance Name | KETOTIFEN FUMARATE |
| Strength Number | .345 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |