| Product NDC: | 68727-600 | 
| Proprietary Name: | Luvox CR | 
| Non Proprietary Name: | fluvoxamine maleate | 
| Active Ingredient(s): | 100 mg/1 & nbsp; fluvoxamine maleate | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 68727-600 | 
| Labeler Name: | Jazz Pharmaceuticals, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022033 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20080228 | 
| Package NDC: | 68727-600-01 | 
| Package Description: | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68727-600-01) | 
| NDC Code | 68727-600-01 | 
| Proprietary Name | Luvox CR | 
| Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68727-600-01) | 
| Product NDC | 68727-600 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | fluvoxamine maleate | 
| Dosage Form Name | CAPSULE, EXTENDED RELEASE | 
| Route Name | ORAL | 
| Start Marketing Date | 20080228 | 
| Marketing Category Name | NDA | 
| Labeler Name | Jazz Pharmaceuticals, Inc. | 
| Substance Name | FLUVOXAMINE MALEATE | 
| Strength Number | 100 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |