| 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] |