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NDC 61958-2101-01 ODEFSEY 200; 25; 25 mg/1; mg/1; mg/1 Details
ODEFSEY 200; 25; 25 mg/1; mg/1; mg/1
ODEFSEY is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE.
MedlinePlus Drug Summary
The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV in adults and children who weigh at least 77 pounds (35 kilograms). Emtricitabine, rilpivirine, and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine, rilpivirine, 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 lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.
Related Packages: 61958-2101-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Emtricitabine, Rilpivirine, and Tenofovir
Product Information
| NDC | 61958-2101 |
|---|---|
| Product ID | 61958-2101_2178fe00-9d08-4b76-bb2e-b4d8cbf33c43 |
| Associated GPIs | 12109903390320 |
| GCN Sequence Number | 075634 |
| GCN Sequence Number Description | emtricitab/rilpiviri/tenof ala TABLET 200-25-25 ORAL |
| HIC3 | W5Q |
| HIC3 Description | ARTV NUCLEOSIDE,NUCLEOTIDE,NON-NUCLEOSIDE RTI COMB |
| GCN | 37633 |
| HICL Sequence Number | 043121 |
| HICL Sequence Number Description | EMTRICITABINE/RILPIVIRINE HCL/TENOFOVIR ALAFENAMIDE FUMARATE |
| Brand/Generic | Brand |
| Proprietary Name | ODEFSEY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 200; 25; 25 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
| Labeler Name | Gilead Sciences, Inc. |
| Pharmaceutical Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hu |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208351 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61958-2101-01 (61958210101)
| NDC Package Code | 61958-2101-1 |
|---|---|
| Billing NDC | 61958210101 |
| Package | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1) |
| Marketing Start Date | 2016-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 117.513 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | ODEFSEY TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |