| Product NDC: | 61958-1101 |
| Proprietary Name: | COMPLERA |
| Non Proprietary Name: | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate |
| Active Ingredient(s): | 200; 25; 300 mg/1; mg/1; mg/1 & nbsp; emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61958-1101 |
| Labeler Name: | Gilead Sciences, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202123 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110810 |
| Package NDC: | 61958-1101-1 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) |
| NDC Code | 61958-1101-1 |
| Proprietary Name | COMPLERA |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) |
| Product NDC | 61958-1101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20110810 |
| Marketing Category Name | NDA |
| Labeler Name | Gilead Sciences, Inc. |
| Substance Name | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
| Strength Number | 200; 25; 300 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmaceutical Classes | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] |