| Product NDC: | 0597-0075 |
| Proprietary Name: | Spiriva |
| Non Proprietary Name: | TIOTROPIUM BROMIDE |
| Active Ingredient(s): | 18 ug/1 & nbsp; TIOTROPIUM BROMIDE |
| Administration Route(s): | ORAL; RESPIRATORY (INHALATION) |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0597-0075 |
| Labeler Name: | Boehringer Ingelheim Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021395 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20051011 |
| Package NDC: | 0597-0075-75 |
| Package Description: | 1 BLISTER PACK in 1 CARTON (0597-0075-75) > 5 CAPSULE in 1 BLISTER PACK |
| NDC Code | 0597-0075-75 |
| Proprietary Name | Spiriva |
| Package Description | 1 BLISTER PACK in 1 CARTON (0597-0075-75) > 5 CAPSULE in 1 BLISTER PACK |
| Product NDC | 0597-0075 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | TIOTROPIUM BROMIDE |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL; RESPIRATORY (INHALATION) |
| Start Marketing Date | 20051011 |
| Marketing Category Name | NDA |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals Inc. |
| Substance Name | TIOTROPIUM BROMIDE MONOHYDRATE |
| Strength Number | 18 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |