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NDC 59676-0800-99 Symtuza 150; 800; 200; 10 mg/1; mg/1; mg/1; mg/1 Details
Symtuza 150; 800; 200; 10 mg/1; mg/1; mg/1; mg/1
Symtuza is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Products LP. The primary component is COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE.
MedlinePlus Drug Summary
The combination of darunavir, cobicistat, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults and children weighing at least 88 pounds (40 kg) who have not been treated with other HIV medications or to replace current medication therapy in certain people already taking HIV medications. The combination of darunavir, cobicistat, emtricitabine, and tenofovir is in a class of medications called antivirals. Darunavir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood. Cobicistat helps to keep darunavir in the body longer so that the medication will have a greater effect. Although the combination of darunavir, cobicistat, emtricitabine, and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting the HIV virus to other people.
Related Packages: 59676-0800-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Darunavir, Cobicistat, Emtricitabine, and Tenofovir
Product Information
| NDC | 59676-0800 |
|---|---|
| Product ID | 59676-800_03342109-cd66-bd0f-e063-6394a90aaf40 |
| Associated GPIs | 12109904200320 |
| GCN Sequence Number | 077819 |
| GCN Sequence Number Description | darunavir/cob/emtri/tenof alaf TABLET 800-150 MG ORAL |
| HIC3 | W0H |
| HIC3 Description | ANTIRETROVIRAL-NUCLEOSIDE,NUCLEOTIDE,PROTEASE INH. |
| GCN | 43968 |
| HICL Sequence Number | 044568 |
| HICL Sequence Number Description | DARUNAVIR ETH/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Symtuza |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 150; 800; 200; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE |
| Labeler Name | Janssen Products LP |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhib |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210455 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59676-0800-99 (59676080099)
| NDC Package Code | 59676-800-99 |
|---|---|
| Billing NDC | 59676080099 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) |
| Marketing Start Date | 2018-07-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |