| NDC Code | 42385-901-03 |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (42385-901-03) |
| Product NDC | 42385-901 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Tenofovir Disoproxil Fumarate |
| Non-Proprietary Name | Tenofovir Disoproxil Fumarate |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20180226 |
| Marketing Category Name | ANDA |
| Application Number | ANDA209550 |
| Manufacturer | Laurus Labs Limited |
| Substance Name | TENOFOVIR DISOPROXIL FUMARATE |
| Strength | 300 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |