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NDC 00597-0155-61 Stiolto Respimat 2.736; 3.124 ug/1; ug/1 Details
Stiolto Respimat 2.736; 3.124 ug/1; ug/1
Stiolto 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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE.
MedlinePlus Drug Summary
Olodaterol oral inhalation is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Olodaterol oral inhalation is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 00597-0155-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olodaterol Oral Inhalation
Tiotropium is used to prevent wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to air sacs in the lungs). Tiotropium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.
Related Packages: 00597-0155-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tiotropium Oral Inhalation
Product Information
| NDC | 00597-0155 |
|---|---|
| Product ID | 0597-0155_dd969dec-1e23-4cac-a42b-2f7f06a07f13 |
| Associated GPIs | 44209902923420 |
| GCN Sequence Number | 074131 |
| GCN Sequence Number Description | tiotropium Br/olodaterol HCl MIST INHAL 2.5-2.5MCG INHALATION |
| HIC3 | B62 |
| HIC3 Description | BETA-ADRENERGIC AND ANTICHOLINERGIC COMBO, INHALED |
| GCN | 38687 |
| HICL Sequence Number | 042048 |
| HICL Sequence Number Description | TIOTROPIUM BROMIDE/OLODATEROL HCL |
| Brand/Generic | Brand |
| Proprietary Name | Stiolto Respimat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tiotropium bromide and olodaterol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 2.736; 3.124 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals Inc. |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA206756 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00597-0155-61 (00597015561)
| NDC Package Code | 0597-0155-61 |
|---|---|
| Billing NDC | 00597015561 |
| Package | 1 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE |
| Marketing Start Date | 2015-05-21 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 115.825 |
| Pricing Unit | GM |
| Effective Date | 2024-01-01 |
| NDC Description | STIOLTO RESPIMAT INHALER (60) |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |