NDC 0310-0800
Tudorza Pressair
Aclidinium Bromide
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.
| Product ID | 0310-0800_1994574d-af74-44a7-a876-b4c4152e755c |
| NDC | 0310-0800 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tudorza Pressair |
| Generic Name | Aclidinium Bromide |
| Dosage Form | Powder, Metered |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2015-07-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA202450 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | ACLIDINIUM BROMIDE |
| Active Ingredient Strength | 400 ug/1 |
| Pharm Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0310-0800-39
1 POUCH in 1 CARTON (0310-0800-39) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER
| Marketing Start Date | 2015-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0310-0800-39 [00310080039]
Tudorza Pressair POWDER, METERED
| Marketing Category | NDA |
| Application Number | NDA202450 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-07-01 |
| Marketing End Date | 2021-01-31 |
NDC 0310-0800-60 [00310080060]
Tudorza Pressair POWDER, METERED
| Marketing Category | NDA |
| Application Number | NDA202450 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-07-01 |
| Marketing End Date | 2021-09-30 |
NDC 0310-0800-95 [00310080095]
Tudorza Pressair POWDER, METERED
| Marketing Category | NDA |
| Application Number | NDA202450 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-07-01 |
| Marketing End Date | 2020-10-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACLIDINIUM BROMIDE | 400 ug/1 |
OpenFDA Data
| SPL SET ID: | acdd5932-375b-4966-8a06-3806ab74c36d |
| Manufacturer | |
| UNII |
Pharmacological Class
- Anticholinergic [EPC]
- Cholinergic Antagonists [MoA]
NDC Crossover Matching brand name "Tudorza Pressair" or generic name "Aclidinium Bromide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-0800 | Tudorza Pressair | aclidinium bromide |
| 72124-002 | Tudorza Pressair | aclidinium bromide |
Trademark Results [Tudorza Pressair]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TUDORZA PRESSAIR 85896045 4509395 Live/Registered |
Almirall, S.A. 2013-04-05 |
 TUDORZA PRESSAIR 85853924 4490481 Live/Registered |
Almirall, S.A. 2013-02-19 |
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