Dutasteride
- Product NDC
- 25000-011
- 11-digit product format
- 250000011
- Labeler code
- 25000
- Product ID
- 25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA204376
- Marketing category
- ANDA
- Marketing start
- 2017-04-27
- 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 |
|---|
| 25000-011-03 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 11 |
| 25000-011-07 | Dutasteride | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 11 |
| 25000-011-27 | Dutasteride | 4 in 1 BOX | CAPSULE, LIQUID FILLED | 4 | | 11 |
| 25000-011-27 | Dutasteride | 2500 in 1 BAG | CAPSULE, LIQUID FILLED | 2500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-011 | DUTASTERIDE CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240814_c4bc56a1-e31c-44fb-bfb5-f77425ff1ea1.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 |
|---|
| 25000-011-03 | 25000001103 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03) | | 2017-04-27 | 0000-00-00 | No | No | Current |
| 25000-011-07 | 25000001107 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07) | | 2017-04-27 | 0000-00-00 | No | No | Current |
| 25000-011-27 | 25000001127 | 4 BAG in 1 BOX (25000-011-27) / 2500 CAPSULE, LIQUID FILLED in 1 BAG | 4 bag | 2017-04-27 | 0000-00-00 | No | No | Current |