Tiotropium Bromide
- Product NDC
- 68180-964
- 11-digit product format
- 681800964
- Labeler code
- 68180
- Product ID
- 68180-964_87de16e4-1447-4bf6-90f6-705829efe684
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tiotropium Bromide
- Dosage form
- CAPSULE
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA211287
- Marketing category
- ANDA
- Marketing start
- 2023-08-16
- 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
- Tiotropium Bromide
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-964-12 | Tiotropium Bromide | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 9 |
| 68180-964-12 | Tiotropium Bromide | 3 in 1 CARTON | CAPSULE | 3 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-964 | TIOTROPIUM BROMIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, 2 package rows | 20250501_496b38ee-45b6-4bb2-a35e-9023c3b73719.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-964-12 | 68180096412 | 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2023-08-16 | No | No | Historical |