Dutasteride and Tamsulosin Hydrochloride
- Product NDC
- 59651-063
- 11-digit product format
- 596510063
- Labeler code
- 59651
- Product ID
- 59651-063_2ad47033-76f3-447d-8a44-21479e9164c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride and Tamsulosin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213300
- Marketing category
- ANDA
- Marketing start
- 2024-07-18
- Substance
- DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
- Active strength
- .5; .4 mg/1; mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], 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
- Dutasteride and Tamsulosin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DUTASTERIDE | .5 mg/1 |
| TAMSULOSIN HYDROCHLORIDE | .4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O0J6XJN02I, 11SV1951MR |
| Rxcui | 996097 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-063-30 | Dutasteride and Tamsulosin Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 59651-063-90 | Dutasteride and Tamsulosin Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-063 | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20240725_2ad47033-76f3-447d-8a44-21479e9164c0.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 |
|---|
| 59651-063-30 | 59651006330 | 30 CAPSULE in 1 BOTTLE (59651-063-30) | 30 capsule | 2024-07-18 | No | No | Current |
| 59651-063-90 | 59651006390 | 90 CAPSULE in 1 BOTTLE (59651-063-90) | 90 capsule | 2024-07-18 | No | No | Current |