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NDC 10370-0176-28 Fluvoxamine Maleate 150 mg/1 Details
Fluvoxamine Maleate 150 mg/1
Fluvoxamine Maleate is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is FLUVOXAMINE MALEATE.
MedlinePlus Drug Summary
Fluvoxamine is used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over) and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Related Packages: 10370-0176-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluvoxamine
Product Information
| NDC | 10370-0176 |
|---|---|
| Product ID | 10370-176_66b909cc-033f-4c55-b7b5-7c45074ef474 |
| Associated GPIs | 58160045107030 |
| GCN Sequence Number | 063768 |
| GCN Sequence Number Description | fluvoxamine maleate CAP ER 24H 150 MG ORAL |
| HIC3 | H2S |
| HIC3 Description | SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) |
| GCN | 99482 |
| HICL Sequence Number | 006338 |
| HICL Sequence Number Description | FLUVOXAMINE MALEATE |
| Brand/Generic | Generic |
| Proprietary Name | Fluvoxamine Maleate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluvoxamine Maleate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 150 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLUVOXAMINE MALEATE |
| Labeler Name | Par Pharmaceutical, Inc. |
| Pharmaceutical Class | Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091476 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 10370-0176-28 (10370017628)
| NDC Package Code | 10370-176-28 |
|---|---|
| Billing NDC | 10370017628 |
| Package | 750 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-28) |
| Marketing Start Date | 2013-03-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |