Dutasteride
- Product NDC
- 72865-140
- 11-digit product format
- 728650140
- Labeler code
- 72865
- Product ID
- 72865-140_64c4cfd9-a320-49f6-ae29-ed9a1f1e3789
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA206574
- Marketing category
- ANDA
- Marketing start
- 2020-03-09
- 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 |
|---|
| 72865-140-30 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 3 |
| 72865-140-90 | Dutasteride | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-140 | DUTASTERIDE CAPSULE, LIQUID FILLED [XLCARE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211001_40ddf119-b0a5-4375-9285-d50a24ed1532.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 |
|---|
| 72865-140-30 | 72865014030 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30) | 2020-03-09 | 0000-00-00 | No | No | Current |
| 72865-140-90 | 72865014090 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-90) | 2020-03-09 | 0000-00-00 | No | No | Current |