Dutasteride
- Product NDC
- 63629-8207
- 11-digit product format
- 636298207
- Labeler code
- 63629
- Product ID
- 63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206574
- Marketing category
- ANDA
- Marketing start
- 2016-10-24
- 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 |
|---|
| 63629-8207-1 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 7 |
| 63629-8207-2 | Dutasteride | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 7 |
| 63629-8207-3 | Dutasteride | 180 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8207 | DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241004_170f01fe-5048-413c-b4cd-8311e1a2728a.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 |
|---|
| 63629-8207-1 | 63629820701 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1) | 2019-08-01 | 0000-00-00 | No | No | Current |
| 63629-8207-2 | 63629820702 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2) | 2020-07-22 | 0000-00-00 | No | No | Current |
| 63629-8207-3 | 63629820703 | 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3) | 2022-04-11 | 0000-00-00 | No | No | Current |