Dutasteride
- Product NDC
- 59651-021
- 11-digit product format
- 596510021
- Labeler code
- 59651
- Product ID
- 59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202660
- Marketing category
- ANDA
- Marketing start
- 2023-01-20
- 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 |
|---|
| 59651-021-30 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 3 |
| 59651-021-90 | 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 |
|---|
| 59651-021 | DUTASTERIDE CAPSULE, LIQUID FILLED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20241025_b32611f3-50ec-45bb-a671-ea10cec7829d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-021-30 | 59651002130 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30) | 2023-01-20 | No | No | Current |
| 59651-021-90 | 59651002190 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90) | 2023-01-20 | No | No | Current |