DULOXETINE HYDROCHLORIDE is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Duloxetine Hydrochloride.
| Product ID | 61919-482_3710dd6f-4689-288b-e054-00144ff8d46c |
| NDC | 61919-482 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DULOXETINE HYDROCHLORIDE |
| Generic Name | Duloxetine Hydrochloride |
| Dosage Form | Capsule, Delayed Release Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203088 |
| Labeler Name | DIRECT RX |
| Substance Name | DULOXETINE HYDROCHLORIDE |
| Active Ingredient Strength | 30 mg/1 |
| Pharm Classes | Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2019-08-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203088 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-16 |
| Marketing Category | ANDA |
| Application Number | ANDA203088 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-05-19 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA203088 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-05-19 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 30 mg/1 |
| SPL SET ID: | b07dc470-5899-40e8-9af2-559ddc75a4be |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0615-7894 | Duloxetine hydrochloride | Duloxetin hydrochloride |
| 0615-7895 | Duloxetine hydrochloride | Duloxetin hydrochloride |
| 0615-8034 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 0615-8035 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 0615-8203 | Duloxetine hydrochloride | Duloxetin hydrochloride |
| 0615-8204 | Duloxetine hydrochloride | Duloxetin hydrochloride |
| 0615-8290 | Duloxetine hydrochloride | Duloxetin hydrochloride |
| 0904-6452 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 68788-9370 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 68788-9371 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 70518-0716 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 70518-0363 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 70518-0686 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 70518-1273 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 70518-1272 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 13668-110 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 13668-109 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 13668-111 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 33342-162 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 33342-160 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 33342-161 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 50090-3317 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 50436-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 50436-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 50436-0018 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 55154-7878 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 55700-165 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 55700-160 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 55700-435 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE |
| 63187-181 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 63187-457 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 63187-172 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 63187-716 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 64725-1100 | Duloxetine hydrochloride | Duloxetine hydrochloride |
| 55154-7889 | Duloxetine Hydrochloride | Duloxetine Hydrochloride |
| 0002-3235 | Cymbalta | Duloxetine hydrochloride |
| 0002-3240 | Cymbalta | Duloxetine hydrochloride |
| 0002-3270 | Cymbalta | Duloxetine hydrochloride |