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NDC 69097-0533-15 Tenofovir disoproxil fumarate 300 mg/1 Details
Tenofovir disoproxil fumarate 300 mg/1
Tenofovir disoproxil fumarate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is TENOFOVIR DISOPROXIL FUMARATE.
MedlinePlus Drug Summary
Tenofovir is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children 2 years of age and older. Tenofovir is also used to treat chronic (long term) HBV in adults and children 2 years of age and older weighing 22 pounds (10 kilograms) or more. Tenofovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood. Although tenofovir will 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 lifestyle changes may decrease the risk of transmitting the HIV virus to other people. Tenofovir will not cure hepatitis B and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Tenofovir may not prevent the spread of hepatitis B to other people.
Related Packages: 69097-0533-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tenofovir
Product Information
| NDC | 69097-0533 |
|---|---|
| Product ID | 69097-533_8a4fe8a6-9007-4d92-be69-bca24535e4e9 |
| Associated GPIs | 12108570100320 |
| GCN Sequence Number | 048843 |
| GCN Sequence Number Description | tenofovir disoproxil fumarate TABLET 300 MG ORAL |
| HIC3 | W5I |
| HIC3 Description | ANTIVIRALS, HIV-SPECIFIC, NUCLEOTIDE ANALOG, RTI |
| GCN | 14822 |
| HICL Sequence Number | 022937 |
| HICL Sequence Number Description | TENOFOVIR DISOPROXIL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Tenofovir disoproxil fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tenofovir disoproxil fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | TENOFOVIR DISOPROXIL FUMARATE |
| Labeler Name | Cipla USA Inc. |
| Pharmaceutical Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078800 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69097-0533-15 (69097053315)
| NDC Package Code | 69097-533-15 |
|---|---|
| Billing NDC | 69097053315 |
| Package | 1000 TABLET in 1 BOTTLE (69097-533-15) |
| Marketing Start Date | 2018-01-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |