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NDC 59676-0563-01 PREZISTA 75 mg/1 Details
PREZISTA 75 mg/1
PREZISTA 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 DARUNAVIR ETHANOLATE.
MedlinePlus Drug Summary
Darunavir is used with a pharmacokinetic booster (a medication that increases the amount of other medications in the body) such as ritonavir (Norvir) or cobicistat (Tybost), and other medications to treat human immunodeficiency virus (HIV) infection in adults and children 3 years of age and older. Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although darunavir does not cure HIV, it 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: 59676-0563-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Darunavir
Product Information
| NDC | 59676-0563 |
|---|---|
| Product ID | 59676-563_02fd607e-f780-dd47-e063-6394a90aad7d |
| Associated GPIs | 12104520000305 |
| GCN Sequence Number | 064811 |
| GCN Sequence Number Description | darunavir TABLET 75 MG ORAL |
| HIC3 | W5P |
| HIC3 Description | ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB |
| GCN | 16759 |
| HICL Sequence Number | 033842 |
| HICL Sequence Number Description | DARUNAVIR |
| Brand/Generic | Brand |
| Proprietary Name | PREZISTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | darunavir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | DARUNAVIR ETHANOLATE |
| Labeler Name | Janssen Products LP |
| Pharmaceutical Class | Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021976 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59676-0563-01 (59676056301)
| NDC Package Code | 59676-563-01 |
|---|---|
| Billing NDC | 59676056301 |
| Package | 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01) |
| Marketing Start Date | 2009-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |