Dutasteride
- Product NDC
- 31722-131
- 11-digit product format
- 317220131
- Labeler code
- 31722
- Product ID
- 31722-131_ea6f1af7-b293-4e0e-9559-fa6085a64c3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- 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 |
|---|
| 31722-131-30 | Dutasteride | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 5 |
| 31722-131-90 | Dutasteride | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-131 | DUTASTERIDE CAPSULE, LIQUID FILLED [CAMBER PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20211001_6b6f8d1b-1759-4fbb-9b95-c20db803e1c2.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 |
|---|
| 31722-131-30 | 31722013130 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-131-30) | 2016-11-07 | 0000-00-00 | No | No | Current |
| 31722-131-90 | 31722013190 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-131-90) | 2016-11-07 | 0000-00-00 | No | No | Current |