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NDC 72789-0221-30 Fluvoxamine Maleate 100 mg/1 Details
Fluvoxamine Maleate 100 mg/1
Fluvoxamine Maleate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, 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: 72789-0221-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluvoxamine
Product Information
| NDC | 72789-0221 |
|---|---|
| Product ID | 72789-221_0634e2f1-9c88-b84c-e063-6294a90a3895 |
| Associated GPIs | |
| GCN Sequence Number | 046210 |
| GCN Sequence Number Description | fluvoxamine maleate TABLET 100 MG ORAL |
| HIC3 | H2S |
| HIC3 Description | SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) |
| GCN | 16349 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLUVOXAMINE MALEATE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075902 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72789-0221-30 (72789022130)
| NDC Package Code | 72789-221-30 |
|---|---|
| Billing NDC | 72789022130 |
| Package | 30 TABLET in 1 BOTTLE, PLASTIC (72789-221-30) |
| Marketing Start Date | 2022-01-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |