Dutasteride
- Product NDC
- 42806-549
- 11-digit product format
- 428060549
- Labeler code
- 42806
- Product ID
- 42806-549_2b367985-feb6-bf97-e063-6294a90aede5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA209909
- Marketing category
- ANDA
- Marketing start
- 2017-11-28
- 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 |
|---|
| 42806-549-09 | Dutasteride | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 3 |
| 42806-549-30 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-549 | DUTASTERIDE CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250110_2ee1eef5-8ec7-46c1-b4fa-13184915448f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-549-09 | 42806054909 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09) | 2017-11-28 | 0000-00-00 | No | No | Current |
| 42806-549-30 | 42806054930 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30) | 2017-11-28 | 0000-00-00 | No | No | Current |