Sertraline is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Sertraline Hydrochloride.
| Product ID | 70518-0201_804fb871-0d3c-6d7d-e053-2991aa0a1e0e |
| NDC | 70518-0201 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Sertraline |
| Generic Name | Sertraline |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077670 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | SERTRALINE HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-01-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077670 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-26 |
| Marketing Category | ANDA |
| Application Number | ANDA077670 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-06 |
| Marketing Category | ANDA |
| Application Number | ANDA077670 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-01-25 |
| Ingredient | Strength |
|---|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
| SPL SET ID: | aed2b158-d1d1-4dcb-8611-2324b2b75a37 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9654 | Sertraline | sertraline hydrochloride |
| 0143-9655 | Sertraline | sertraline hydrochloride |
| 0143-9656 | Sertraline | sertraline hydrochloride |
| 0615-6558 | Sertraline | Sertraline Hydrochloride |
| 0615-6559 | Sertraline | Sertraline Hydrochloride |
| 0615-6560 | Sertraline | Sertraline Hydrochloride |
| 0615-7989 | Sertraline | Sertraline |
| 0615-7990 | Sertraline | Sertraline |
| 0615-7991 | Sertraline | Sertraline |
| 0904-6924 | Sertraline | Sertraline |
| 0904-6925 | Sertraline | Sertraline |
| 0904-6926 | Sertraline | Sertraline |
| 33261-346 | Sertraline | Sertraline |
| 42708-068 | Sertraline | Sertraline |
| 43353-809 | SERTRALINE | Sertraline |
| 43353-812 | SERTRALINE | Sertraline |
| 43353-817 | SERTRALINE | Sertraline |
| 50090-0989 | Sertraline | Sertraline |
| 50090-0991 | Sertraline | Sertraline |
| 50090-3562 | SERTRALINE | Sertraline |
| 50090-5848 | Sertraline | Sertraline |
| 50436-3520 | Sertraline | Sertraline |
| 50436-6304 | SERTRALINE | Sertraline Hydrochloride |
| 51655-352 | Sertraline | Sertraline |
| 51655-830 | Sertraline | Sertraline |
| 51655-979 | Sertraline | Sertraline |
| 53217-380 | Sertraline | Sertraline |
| 55154-3569 | Sertraline | Sertraline |
| 55154-3570 | Sertraline | Sertraline |
| 68071-4400 | Sertraline | Sertraline |
| 68180-351 | Sertraline | Sertraline |
| 68180-352 | Sertraline | Sertraline |
| 68180-353 | Sertraline | Sertraline |
| 70518-0153 | Sertraline | Sertraline |
| 70518-0240 | Sertraline | Sertraline |
| 70518-0201 | Sertraline | Sertraline |
| 70518-0378 | Sertraline | Sertraline |
| 70518-0938 | Sertraline | Sertraline |
| 70518-1040 | Sertraline | Sertraline |
| 70518-1290 | Sertraline | Sertraline |
| 70518-1461 | Sertraline | Sertraline |
| 70518-1617 | Sertraline | Sertraline |
| 71335-0404 | Sertraline | Sertraline |
| 76282-212 | SERTRALINE | SERTRALINE |
| 76282-213 | SERTRALINE | SERTRALINE |
| 76282-214 | SERTRALINE | SERTRALINE |
| 55154-6627 | Sertraline | Sertraline |
| 55700-225 | Sertraline | Sertraline |
| 55700-222 | Sertraline | Sertraline |
| 57297-352 | Sertraline | Sertraline |