Spiriva
- Product NDC
- 50090-4414
- 11-digit product format
- 500904414
- Labeler code
- 50090
- Product ID
- 50090-4414_22fe8b5c-76a9-407d-9fec-9761e54555eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TIOTROPIUM BROMIDE
- Dosage form
- CAPSULE
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- A-S Medication Solutions
- Application
- NDA021395
- Marketing category
- NDA
- Marketing start
- 2005-10-11
- Marketing end
- 0000-00-00
- Substance
- TIOTROPIUM BROMIDE MONOHYDRATE
- Active strength
- 18 ug/1
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 48c4d28d-b099-457f-b725-6536a67545d9 | Product name | 1 | 20240723 |
| e5bad22a-8b64-476c-b12b-bcb1efd8adfc | Product name | 3 | 20210727 |
| b2bc1652-3709-4d21-bd76-c433f7f7103e | Product name | 1 | 20150610 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4414-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-ea5e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4414-0 | Spiriva | 9 in 1 CARTON | CAPSULE | 9 | 3 | |
| 50090-4414-0 | Spiriva | 10 in 1 BLISTER PACK | CAPSULE | 10 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4414-0 | EA - Each | 50090-4414 | bdef023d-1f60-4df5-b4d1-b0a60a4d62a4 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4414 | SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS] | 3 | Legacy NDC, 2 package rows | 20200516_25a4cb05-64a8-44b6-88c8-4292a5292e92.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 580261 | SPIRIVA HandiHaler 18 MCG Inhalation Powder | PSN | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 485032 | tiotropium 18 MCG Inhalation Powder | PSN | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 580261 | tiotropium 0.018 MG Inhalation Powder [Spiriva] | SBD | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 485032 | tiotropium 0.018 MG Inhalation Powder | SCD | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 580261 | Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder | SY | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 580261 | Spiriva HandiHaler 18 MCG Inhalation Powder | SY | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 485032 | tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder | SY | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
| 485032 | tiotropium 18 MCG Inhalation Powder | SY | 25a4cb05-64a8-44b6-88c8-4292a5292e92 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4414-0 | 50090441400 | 9 BLISTER PACK in 1 CARTON (50090-4414-0) > 10 CAPSULE in 1 BLISTER PACK | 9 blister pack | 2019-07-16 | 0000-00-00 | No | No | Current |