Dutasteride
- Product NDC
- 71205-039
- 11-digit product format
- 712050039
- Labeler code
- 71205
- Product ID
- 71205-039_4ca84780-9497-4cc3-a5bb-01b7b55ee3e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203118
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- Substance
- DUTASTERIDE
- Active strength
- .5 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dutasteride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DUTASTERIDE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O0J6XJN02I |
| Rxcui | 351172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-039-30 | Dutasteride | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 71205-039-60 | Dutasteride | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 71205-039-90 | Dutasteride | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-039 | DUTASTERIDE CAPSULE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191122_f95c3fff-1e15-4ab8-a839-6a65a5828dbb.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 |
|---|
| 71205-039-30 | 71205003930 | 30 CAPSULE in 1 BOTTLE (71205-039-30) | 30 capsule | 2018-05-01 | 0000-00-00 | No | No | Current |
| 71205-039-60 | 71205003960 | 60 CAPSULE in 1 BOTTLE (71205-039-60) | 60 capsule | 2018-05-01 | 0000-00-00 | No | No | Current |
| 71205-039-90 | 71205003990 | 90 CAPSULE in 1 BOTTLE (71205-039-90) | 90 capsule | 2018-05-01 | 0000-00-00 | No | No | Current |