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NDC 00310-0800-60 Tudorza Pressair 400 ug/1 Details
Tudorza Pressair 400 ug/1
Tudorza Pressair is a RESPIRATORY (INHALATION) POWDER, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is ACLIDINIUM BROMIDE.
MedlinePlus Drug Summary
Aclidinium is used as a long term treatment 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). Aclidinium 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: 00310-0800-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aclidinium Oral Inhalation
Product Information
| NDC | 00310-0800 |
|---|---|
| Product ID | 0310-0800_392d891f-7292-4fda-9f05-f1c21586e4d5 |
| Associated GPIs | 44100007108020 |
| GCN Sequence Number | 069855 |
| GCN Sequence Number Description | aclidinium bromide AER POW BA 400 MCG INHALATION |
| HIC3 | B61 |
| HIC3 Description | ANTICHOLINERGICS, ORALLY INHALED LONG ACTING |
| GCN | 33084 |
| HICL Sequence Number | 039528 |
| HICL Sequence Number Description | ACLIDINIUM BROMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Tudorza Pressair |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | aclidinium bromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | ug/1 |
| Substance Name | ACLIDINIUM BROMIDE |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA202450 |
| Listing Certified Through | n/a |
Package
NDC 00310-0800-60 (00310080060)
| NDC Package Code | 0310-0800-60 |
|---|---|
| Billing NDC | 00310080060 |
| Package | 1 POUCH in 1 CARTON (0310-0800-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| Marketing Start Date | 2015-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |