NDC 69189-0701
Truvada
Emtricitabine And Tenofovir Disoproxil Fumarate
Truvada is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Emtricitabine; Tenofovir Disoproxil Fumarate.
| Product ID | 69189-0701_79dadcfd-c3a6-4ac9-8de7-e00d2b781a63 |
| NDC | 69189-0701 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Truvada |
| Generic Name | Emtricitabine And Tenofovir Disoproxil Fumarate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-05-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021752 |
| Labeler Name | Avera McKennan Hospital |
| Substance Name | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
| Active Ingredient Strength | 200 mg/1; mg/1 |
| Pharm Classes | Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],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] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 69189-0701-1
1 TABLET, FILM COATED in 1 DOSE PACK (69189-0701-1)
| Marketing Start Date | 2015-05-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 69189-0701-1 [69189070101]
Truvada TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021752 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-05-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| EMTRICITABINE | 200 mg/1 |
OpenFDA Data
| SPL SET ID: | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Nucleoside Analog [EXT]
- Nucleoside Reverse Transcriptase Inhibitors [MoA]
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- 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]
NDC Crossover Matching brand name "Truvada" or generic name "Emtricitabine And Tenofovir Disoproxil Fumarate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 35356-070 | Truvada | emtricitabine and tenofovir disoproxil fumarate |
| 50090-0870 | Truvada | emtricitabine and tenofovir disoproxil fumarate |
| 52959-969 | Truvada | emtricitabine and tenofovir disoproxil fumarate |
| 53808-0805 | Truvada | emtricitabine and tenofovir disoproxil fumarate |
| 61919-669 | TRUVADA | emtricitabine and tenofovir disoproxil fumarate |
| 61958-0701 | Truvada | emtricitabine and tenofovir disoproxil fumarate |
| 68071-2112 | Truvada | Truvada |
| 69189-0701 | Truvada | Truvada |
| 70518-0097 | Truvada | Truvada |
| 61958-0704 | Truvada | Truvada |
| 61958-0705 | Truvada | Truvada |
| 61958-0703 | Truvada | Truvada |
| 63629-7581 | Truvada | Truvada |
| 67296-1237 | Truvada | Truvada |
| 0093-7607 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 0093-7704 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 0378-1930 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 0904-7172 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 16714-534 | Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine and tenofovir disoproxil fumarate |
| 31722-560 | Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine and tenofovir disoproxil fumarate |
| 33342-106 | Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine and tenofovir disoproxil fumarate |
| 42291-439 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 42385-913 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 42385-953 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 42543-719 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate |
| 50090-5957 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
| 51407-112 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate |
| 60219-2092 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 60219-2093 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 60219-2094 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 60219-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate |
| 60505-4202 | Emtricitabine and Tenofovir Disoproxil Fumarate | emtricitabine and tenofovir disoproxil fumarate |
Trademark Results [Truvada]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUVADA 78239720 2915213 Live/Registered |
Gilead Sciences, Inc. 2003-04-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.