| Product NDC: | 0574-0840 |
| Proprietary Name: | Ibutilide Fumarate |
| Non Proprietary Name: | Ibutilide Fumarate |
| Active Ingredient(s): | .1 mg/mL & nbsp; Ibutilide Fumarate |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0574-0840 |
| Labeler Name: | Paddock Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090240 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100113 |
| Package NDC: | 0574-0840-01 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (0574-0840-01) > 10 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 0574-0840-01 |
| Proprietary Name | Ibutilide Fumarate |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0574-0840-01) > 10 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 0574-0840 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ibutilide Fumarate |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20100113 |
| Marketing Category Name | ANDA |
| Labeler Name | Paddock Laboratories, Inc. |
| Substance Name | IBUTILIDE FUMARATE |
| Strength Number | .1 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |