Silodosin
- Product NDC
- 33342-384
- 11-digit product format
- 333420384
- Labeler code
- 33342
- Product ID
- 33342-384_4a96f732-bbce-426f-9780-89115cac638b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Silodosin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA211166
- Marketing category
- ANDA
- Marketing start
- 2018-12-03
- 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 |
|---|
| 33342-384-07 | Silodosin | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 33342-384-10 | Silodosin | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
| 33342-384-12 | Silodosin | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 3 |
| 33342-384-12 | Silodosin | 100 in 1 CARTON | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-384 | SILODOSIN CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220702_58af9a98-b1a1-4f30-b535-6647f1effed4.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 |
|---|
| 33342-384-07 | 33342038407 | 30 CAPSULE in 1 BOTTLE (33342-384-07) | 30 capsule | 2018-12-03 | 0000-00-00 | No | No | Current |
| 33342-384-10 | 33342038410 | 90 CAPSULE in 1 BOTTLE (33342-384-10) | 90 capsule | 2018-12-03 | 0000-00-00 | No | No | Current |
| 33342-384-12 | 33342038412 | 100 BLISTER PACK in 1 CARTON (33342-384-12) / 10 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2018-12-03 | 0000-00-00 | No | No | Current |