Spiriva Respimat is a Respiratory (inhalation) Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Tiotropium Bromide Anhydrous.
| Product ID | 0597-0100_2ef119c5-33ec-4d21-a3b4-01d07875253e |
| NDC | 0597-0100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Spiriva Respimat |
| Generic Name | Tiotropium Bromide Inhalation Spray |
| Dosage Form | Spray, Metered |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2014-09-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021936 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | TIOTROPIUM BROMIDE ANHYDROUS |
| Active Ingredient Strength | 3 ug/1 |
| Pharm Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2014-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA021936 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2014-09-30 |
| Marketing Category | NDA |
| Application Number | NDA021936 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2019-03-15 |
| Marketing Category | NDA |
| Application Number | NDA021936 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2014-09-30 |
| Marketing Category | NDA |
| Application Number | NDA021936 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2018-07-02 |
| Ingredient | Strength |
|---|---|
| TIOTROPIUM BROMIDE | 3.124 ug/1 |
| SPL SET ID: | 7b656b14-fcaa-2741-f6f0-e0be48971c02 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0100 | Spiriva Respimat | tiotropium bromide inhalation spray |
| 0597-0160 | Spiriva Respimat | tiotropium bromide inhalation spray |