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NDC 00049-0050-01 Zoloft 20 mg/mL Details
Zoloft 20 mg/mL
Zoloft is a ORAL SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ROERIG. The primary component is SERTRALINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.
Related Packages: 00049-0050-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sertraline
Product Information
| NDC | 00049-0050 |
|---|---|
| Product ID | 0049-0050_7e6deb58-5cba-493f-a22c-fa59b5c2f58a |
| Associated GPIs | 58160070101320 |
| GCN Sequence Number | 046230 |
| GCN Sequence Number Description | sertraline HCl ORAL CONC 20 MG/ML ORAL |
| HIC3 | H2S |
| HIC3 Description | SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) |
| GCN | 16376 |
| HICL Sequence Number | 006324 |
| HICL Sequence Number Description | SERTRALINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Zoloft |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sertraline hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | SERTRALINE HYDROCHLORIDE |
| Labeler Name | ROERIG |
| Pharmaceutical Class | Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020990 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00049-0050-01 (00049005001)
| NDC Package Code | 0049-0050-01 |
|---|---|
| Billing NDC | 00049005001 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2017-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |