Dutasteride and tamsulosin hydrochloride
- Product NDC
- 68382-640
- 11-digit product format
- 683820640
- Labeler code
- 68382
- Product ID
- 68382-640_9e44a416-1d3d-418c-a113-f6c65175b564
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride and tamsulosin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- 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 |
|---|
| 68382-640-06 | Dutasteride and tamsulosin hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 68382-640-16 | Dutasteride and tamsulosin hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-640 | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241113_d6557691-7910-4006-9268-410583e437d1.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 |
|---|
| 68382-640-06 | 68382064006 | 30 CAPSULE in 1 BOTTLE (68382-640-06) | 30 capsule | 2018-06-04 | 0000-00-00 | No | No | Current |
| 68382-640-16 | 68382064016 | 90 CAPSULE in 1 BOTTLE (68382-640-16) | 90 capsule | 2018-06-04 | 0000-00-00 | No | No | Current |