Dutasteride
- Product NDC
- 65162-750
- 11-digit product format
- 651620750
- Labeler code
- 65162
- Product ID
- 65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203118
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- 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 |
|---|
| 65162-750-03 | Dutasteride | 30 in 1 BOTTLE | CAPSULE | 30 | | 14 |
| 65162-750-09 | Dutasteride | 90 in 1 BOTTLE | CAPSULE | 90 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DUTASTERIDE | ACTIVE INGREDIENT | O0J6XJN02I | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| DUTASTERIDE | ACTIVE MOIETY | O0J6XJN02I | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| GLYCERYL CAPRYLATE/CAPRATE | INACTIVE INGREDIENT | G7515SW10N | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-750 | DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241027_e537c60d-9ba2-4e7f-a405-2b915dcd7ead.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-750-03 | 65162075003 | 30 CAPSULE in 1 BOTTLE (65162-750-03) | 30 capsule | 2015-11-02 | 0000-00-00 | No | No | Current |
| 65162-750-09 | 65162075009 | 90 CAPSULE in 1 BOTTLE (65162-750-09) | 90 capsule | 2015-11-02 | 0000-00-00 | No | No | Current |