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NDC 42385-0953-90 Emtricitabine and Tenofovir Disoproxil Fumarate 200; 300 mg/1; mg/1 Details
Emtricitabine and Tenofovir Disoproxil Fumarate 200; 300 mg/1; mg/1
Emtricitabine and Tenofovir Disoproxil Fumarate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Laurus Labs Limited. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.
MedlinePlus Drug Summary
The combination of emtricitabine and tenofovir (Descovy, Truvada) is used along with other medications to treat HIV in adults and children who weigh at least 37 pounds (17 kg). Emtricitabine and tenofovir (Truvada) is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection) in high-risk adults and teenagers who weigh at least 77 pounds (35 kg). Emtricitabine 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 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: 42385-0953-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Emtricitabine and Tenofovir
Product Information
| NDC | 42385-0953 |
|---|---|
| Product ID | 42385-953_f87bdc93-cb49-4c2f-b8db-f8b8e57d0367 |
| Associated GPIs | 12109902300320 |
| GCN Sequence Number | 057883 |
| GCN Sequence Number Description | emtricitabine/tenofovir (TDF) TABLET 200-300 MG ORAL |
| HIC3 | W5O |
| HIC3 Description | ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG |
| GCN | 23152 |
| HICL Sequence Number | 026515 |
| HICL Sequence Number Description | EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Emtricitabine and Tenofovir Disoproxil Fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Emtricitabine and Tenofovir Disoproxil Fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200; 300 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
| Labeler Name | Laurus Labs Limited |
| Pharmaceutical Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleosi |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212114 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42385-0953-90 (42385095390)
| NDC Package Code | 42385-953-90 |
|---|---|
| Billing NDC | 42385095390 |
| Package | 90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90) |
| Marketing Start Date | 2019-07-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |