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NDC 65862-0013-99 Sertraline Hydrochloride 100 mg/1 Details
Sertraline Hydrochloride 100 mg/1
Sertraline Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. 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: 65862-0013-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sertraline
Product Information
| NDC | 65862-0013 |
|---|---|
| Product ID | 65862-013_4680748c-467b-4a7c-9387-848919a206bc |
| Associated GPIs | 58160070100320 |
| GCN Sequence Number | 046229 |
| GCN Sequence Number Description | sertraline HCl TABLET 100 MG ORAL |
| HIC3 | H2S |
| HIC3 Description | SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) |
| GCN | 16375 |
| HICL Sequence Number | 006324 |
| HICL Sequence Number Description | SERTRALINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Sertraline Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sertraline Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | SERTRALINE HYDROCHLORIDE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077206 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0013-99 (65862001399)
| NDC Package Code | 65862-013-99 |
|---|---|
| Billing NDC | 65862001399 |
| Package | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-013-99) |
| Marketing Start Date | 2007-02-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |