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NDC 50090-4248-00 Spiriva 18 ug/1 Details
Spiriva 18 ug/1
Spiriva is a ORAL; RESPIRATORY (INHALATION) CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is TIOTROPIUM BROMIDE MONOHYDRATE.
MedlinePlus Drug Summary
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: 50090-4248-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tiotropium Oral Inhalation
Product Information
| NDC | 50090-4248 |
|---|---|
| Product ID | 50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76 |
| Associated GPIs | 44100080100120 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Spiriva |
| Proprietary Name Suffix | HandiHaler |
| Non-Proprietary Name | TIOTROPIUM BROMIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL; RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 18 |
| Active Ingredient Units | ug/1 |
| Substance Name | TIOTROPIUM BROMIDE MONOHYDRATE |
| Labeler Name | A-S Medication Solutions |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021395 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50090-4248-00 (50090424800)
| NDC Package Code | 50090-4248-0 |
|---|---|
| Billing NDC | 50090424800 |
| Package | 3 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2019-04-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |