SILODOSIN
- Product NDC
- 82619-114
- 11-digit product format
- 826190114
- Labeler code
- 82619
- Product ID
- 82619-114_51397c86-1c54-06a7-e063-6394a90a1ff3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- silodosin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA213230
- Marketing category
- ANDA
- Marketing start
- 2024-11-14
- Substance
- SILODOSIN
- Active strength
- 8 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SILODOSIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILODOSIN | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CUZ39LUY82 |
| Rxcui | 809477, 826612 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82619-114-01 | SILODOSIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
| 82619-114-02 | SILODOSIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82619-114 | SILODOSIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20241115_43f83422-680f-411e-bbc3-2b092e64a017.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 |
|---|
| 82619-114-01 | 82619011401 | 30 CAPSULE in 1 BOTTLE (82619-114-01) | 30 capsule | 2024-11-14 | No | No | Current |
| 82619-114-02 | 82619011402 | 90 CAPSULE in 1 BOTTLE (82619-114-02) | 90 capsule | 2024-11-14 | No | No | Current |