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NDC 69097-0248-03 Darunavir 600 and 800 mg 600 mg/1 Details
Darunavir 600 and 800 mg 600 mg/1
Darunavir 600 and 800 mg is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is DARUNAVIR HYDRATE.
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: 69097-0248-03Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Darunavir
Product Information
| NDC | 69097-0248 |
|---|---|
| Product ID | 69097-248_bdbfc235-3cca-4fa0-be70-9c34cfb91feb |
| Associated GPIs | |
| GCN Sequence Number | 063719 |
| GCN Sequence Number Description | darunavir TABLET 600 MG ORAL |
| HIC3 | W5P |
| HIC3 Description | ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB |
| GCN | 99434 |
| HICL Sequence Number | 033842 |
| HICL Sequence Number Description | DARUNAVIR |
| Brand/Generic | Generic |
| Proprietary Name | Darunavir 600 and 800 mg |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | darunavir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | DARUNAVIR HYDRATE |
| Labeler Name | Cipla USA Inc. |
| 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 | ANDA |
| Application Number | ANDA206288 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69097-0248-03 (69097024803)
| NDC Package Code | 69097-248-03 |
|---|---|
| Billing NDC | 69097024803 |
| Package | 60 TABLET in 1 BOTTLE (69097-248-03) |
| Marketing Start Date | 2023-11-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 3.74957 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DARUNAVIR 600 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |