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 |