DULOXETINE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Duloxetine Hydrochloride.
| Product ID | 43547-379_1687aea0-978e-4fd3-a299-1f6121fc9523 |
| NDC | 43547-379 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DULOXETINE |
| Generic Name | Duloxetine |
| Dosage Form | Capsule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-01-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206653 |
| Labeler Name | Solco Healthcare US, LLC |
| Substance Name | DULOXETINE HYDROCHLORIDE |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2016-01-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-01-20 |
| Marketing Category | ANDA |
| Application Number | ANDA206653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-01-20 |
| Marketing Category | ANDA |
| Application Number | ANDA206653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-01-20 |
| Marketing Category | ANDA |
| Application Number | ANDA206653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-01-20 |
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 20 mg/1 |
| SPL SET ID: | a105a648-6a97-4151-b9de-d7eac90a8f79 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7542 | Duloxetine | Duloxetine |
| 0093-7543 | Duloxetine | Duloxetine |
| 0093-7544 | Duloxetine | Duloxetine |
| 0228-2890 | Duloxetine | Duloxetine |
| 0228-2891 | Duloxetine | Duloxetine |
| 0228-2892 | Duloxetine | Duloxetine |
| 0904-7043 | Duloxetine | Duloxetine Hydrochloride |
| 0904-7044 | Duloxetine | Duloxetine Hydrochloride |
| 0904-7045 | Duloxetine | Duloxetine Hydrochloride |
| 23155-654 | duloxetine | duloxetine |
| 23155-655 | duloxetine | duloxetine |
| 23155-656 | duloxetine | duloxetine |
| 25000-608 | Duloxetine | Duloxetine Hydrochloride |
| 25000-609 | Duloxetine | Duloxetine Hydrochloride |
| 25000-610 | Duloxetine | Duloxetine Hydrochloride |
| 27241-097 | Duloxetine | Duloxetine |
| 27241-098 | Duloxetine | Duloxetine |
| 67877-264 | Duloxetine | Duloxetine |
| 67877-265 | Duloxetine | Duloxetine |
| 67877-263 | Duloxetine | Duloxetine |
| 68001-255 | Duloxetine | Duloxetine |
| 68001-256 | Duloxetine | Duloxetine |
| 68001-257 | Duloxetine | Duloxetine |
| 68071-4700 | Duloxetine | Duloxetine |
| 68084-692 | Duloxetine | Duloxetine |
| 68084-675 | Duloxetine | Duloxetine |
| 68084-683 | Duloxetine | Duloxetine |
| 68151-4727 | Duloxetine | Duloxetine |
| 68180-294 | Duloxetine | Duloxetine |
| 68180-297 | Duloxetine | Duloxetine |
| 68180-295 | Duloxetine | Duloxetine |
| 68180-296 | Duloxetine | Duloxetine |
| 68382-385 | Duloxetine | Duloxetine |
| 68382-386 | Duloxetine | Duloxetine |
| 68382-387 | Duloxetine | Duloxetine |
| 68788-6427 | duloxetine | duloxetine |
| 68788-9262 | Duloxetine | Duloxetine |
| 68788-9266 | Duloxetine | Duloxetine |
| 69097-298 | duloxetine | duloxetine |
| 69097-297 | duloxetine | duloxetine |
| 69097-299 | duloxetine | duloxetine |
| 70518-0491 | Duloxetine | Duloxetine |
| 70518-1066 | Duloxetine | Duloxetine |
| 70518-0937 | Duloxetine | Duloxetine |
| 70518-1054 | Duloxetine | Duloxetine |
| 70518-1139 | Duloxetine | Duloxetine |
| 70518-0685 | Duloxetine | Duloxetine |
| 70518-1128 | DULOXETINE | DULOXETINE |
| 70518-1011 | Duloxetine | Duloxetine |
| 70518-1244 | Duloxetine | Duloxetine |