DUTASTERIDE
- Product NDC
- 84091-100
- 11-digit product format
- 840910100
- Labeler code
- 84091
- Product ID
- 84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DUTASTERIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Banyan Pharma LLC
- Application
- ANDA204705
- Marketing category
- ANDA
- Marketing start
- 2025-12-31
- 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 |
|---|
| 84091-100-90 | DUTASTERIDE | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84091-100-90 | 84091010090 | 90 CAPSULE in 1 BOTTLE (84091-100-90) | 90 capsule | 2025-12-31 | No | No | Historical |