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NDC 65862-0497-30 Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate 600; 200; 300 mg/1; mg/1; mg/1 Details
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate 600; 200; 300 mg/1; mg/1; mg/1
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.
MedlinePlus Drug Summary
The combination of efavirenz, emtricitabine, and tenofovir is used alone or along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children weighing more than 40 kg (88 lb). Efavirenz is in a class of medications non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine and tenofovir are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the body. Although efavirenz, 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 lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.
Related Packages: 65862-0497-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Efavirenz, Emtricitabine, and Tenofovir
Product Information
| NDC | 65862-0497 |
|---|---|
| Product ID | 65862-497_e45a9953-97a0-4885-acbd-5af0f22c4f74 |
| Associated GPIs | 12109903300320 |
| GCN Sequence Number | 061173 |
| GCN Sequence Number Description | efavirenz/emtricit/tenofovr df TABLET 600-200MG ORAL |
| HIC3 | W5Q |
| HIC3 Description | ARTV NUCLEOSIDE,NUCLEOTIDE,NON-NUCLEOSIDE RTI COMB |
| GCN | 27346 |
| HICL Sequence Number | 033888 |
| HICL Sequence Number Description | EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 600; 200; 300 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [ |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203041 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0497-30 (65862049730)
| NDC Package Code | 65862-497-30 |
|---|---|
| Billing NDC | 65862049730 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (65862-497-30) |
| Marketing Start Date | 2021-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.29148 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | EFAVIRENZ-EMTRICITABINE-TENOFOV DISOP FUM 600-200-300 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |