| Product NDC: | 0430-0210 |
| Proprietary Name: | SARAFEM |
| Non Proprietary Name: | fluoxetine hydrochloride |
| Active Ingredient(s): | 10 mg/1 & nbsp; fluoxetine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0430-0210 |
| Labeler Name: | Warner Chilcott (US), LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021860 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080624 |
| Package NDC: | 0430-0210-14 |
| Package Description: | 72 CARTON in 1 CASE (0430-0210-14) > 4 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK |
| NDC Code | 0430-0210-14 |
| Proprietary Name | SARAFEM |
| Package Description | 72 CARTON in 1 CASE (0430-0210-14) > 4 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK |
| Product NDC | 0430-0210 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fluoxetine hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20080624 |
| Marketing Category Name | NDA |
| Labeler Name | Warner Chilcott (US), LLC |
| Substance Name | FLUOXETINE HYDROCHLORIDE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |