Spiriva
- Product NDC
- 50090-7645
- 11-digit product format
- 500907645
- Labeler code
- 50090
- Product ID
- 50090-7645_70e86c70-cb36-45d0-853c-9840b3dad9b9
- 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
- Substance
- TIOTROPIUM BROMIDE MONOHYDRATE
- Active strength
- 18 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
- Spiriva
- Brand name suffix
- HandiHaler
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIOTROPIUM BROMIDE MONOHYDRATE | 18 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L64SXO195N |
| Rxcui | 485032, 580261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7645-0 | Spiriva HandiHaler | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
| 50090-7645-0 | Spiriva HandiHaler | 3 in 1 CARTON | CAPSULE | 3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7645-0 | 50090764500 | 3 BLISTER PACK in 1 CARTON (50090-7645-0) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2025-08-29 | No | No | Historical |