Tudorza Pressair
- Product NDC
- 70515-002
- 11-digit product format
- 705150002
- Labeler code
- 70515
- Product ID
- 70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aclidinium bromide
- Dosage form
- POWDER, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Covis Pharma US, Inc
- Application
- NDA202450
- Marketing category
- NDA
- Marketing start
- 2015-07-01
- Substance
- ACLIDINIUM BROMIDE
- Active strength
- 400 ug/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tudorza Pressair
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACLIDINIUM BROMIDE | 400 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UQW7UF9N91 |
| Rxcui | 1303102, 1303107, 1607111, 1607112 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70515-002-01 | Tudorza Pressair | 1 in 1 POUCH | POWDER, METERED | 1 | | 2 |
| 70515-002-01 | Tudorza Pressair | 1 in 1 CARTON | POWDER, METERED | 1 | | 2 |
| 70515-002-02 | Tudorza Pressair | 1 in 1 CARTON | POWDER, METERED | 1 | | 2 |
| 70515-002-02 | Tudorza Pressair | 1 in 1 POUCH | POWDER, METERED | 1 | | 2 |
| 70515-002-03 | Tudorza Pressair | 1 in 1 CARTON | POWDER, METERED | 1 | | 2 |
| 70515-002-03 | Tudorza Pressair | 1 in 1 POUCH | POWDER, METERED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70515-002 | TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) POWDER, METERED [COVIS PHARMA US, INC] | 2 | Current NDC, 6 package rows | 20231208_6f92cceb-a63f-4470-99b6-56179d98f10f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1607111 | aclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT | PSN | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303102 | aclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607112 | Tudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT | PSN | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303107 | Tudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT | PSN | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607112 | 30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [Tudorza] | SBD | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303107 | 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [Tudorza] | SBD | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607111 | 30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler | SCD | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303102 | 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler | SCD | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607112 | 30 ACTUAT Tudorza 0.4 MG/ACTUAT Dry Powder Inhaler | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303102 | 60 ACTUAT aclidinium bromide 400 MCG/ACTUAT Dry Powder Inhaler | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303107 | 60 ACTUAT Tudorza 0.4 MG/ACTUAT Dry Powder Inhaler | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303102 | aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607111 | aclidinium bromide 400 MCG/ACTUAT (375 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 30 ACTUAT | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303107 | Tudorza 400 MCG/ACTUAT (aclidinium bromide 375 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 60 ACTUAT | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1303107 | Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
| 1607112 | Tudorza Pressair 400 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAT | SY | 6f92cceb-a63f-4470-99b6-56179d98f10f | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70515-002-01 | 70515000201 | 1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER | 1 pouch | 2015-07-01 | No | No | Current |
| 70515-002-02 | 70515000202 | 1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER | 1 pouch | 2015-07-01 | No | No | Current |
| 70515-002-03 | 70515000203 | 1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER | 1 pouch | 2015-07-01 | Yes | No | Current |