Dutasteride and tamsulosin hydrochloride
- Product NDC
- 70771-1356
- 11-digit product format
- 707711356
- Labeler code
- 70771
- Product ID
- 70771-1356_63766352-5eec-410d-a059-3c07a9f17a3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride and tamsulosin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA207769
- Marketing category
- ANDA
- Marketing start
- 2018-06-04
- 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 |
|---|
| 70771-1356-3 | Dutasteride and tamsulosin hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
| 70771-1356-9 | Dutasteride and tamsulosin hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1356 | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241201_4b89b07e-9d19-47a2-bd53-bc5eef9deed1.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 |
|---|
| 70771-1356-3 | 70771135603 | 30 CAPSULE in 1 BOTTLE (70771-1356-3) | 30 capsule | 2018-06-04 | 0000-00-00 | No | No | Current |
| 70771-1356-9 | 70771135609 | 90 CAPSULE in 1 BOTTLE (70771-1356-9) | 90 capsule | 2018-06-04 | 0000-00-00 | No | No | Current |