Silodosin
- Product NDC
- 31722-635
- 11-digit product format
- 317220635
- Labeler code
- 31722
- Product ID
- 31722-635_1a1f75e4-0d3a-55a0-e063-6294a90af183
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Silodosin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204793
- Marketing category
- ANDA
- Marketing start
- 2020-02-14
- Substance
- SILODOSIN
- Active strength
- 4 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Silodosin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILODOSIN | 4 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 |
|---|
| 31722-635-30 | Silodosin | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 31722-635-31 | Silodosin | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 31722-635-90 | Silodosin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
| 31722-635-91 | Silodosin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-635 | SILODOSIN (SILODOSIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240606_b9880aad-5fbe-470b-a7a0-d963ba4bc98b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-635-30 | 31722063530 | 30 CAPSULE in 1 BOTTLE (31722-635-30) | 30 capsule | 2020-02-14 | 0000-00-00 | No | No | Current |
| 31722-635-31 | 31722063531 | 30 CAPSULE in 1 BOTTLE (31722-635-31) | 30 capsule | 2020-02-14 | 0000-00-00 | No | No | Current |
| 31722-635-90 | 31722063590 | 90 CAPSULE in 1 BOTTLE (31722-635-90) | 90 capsule | 2020-02-14 | 0000-00-00 | No | No | Current |
| 31722-635-91 | 31722063591 | 90 CAPSULE in 1 BOTTLE (31722-635-91) | 90 capsule | 2020-02-14 | 0000-00-00 | No | No | Current |