Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 50090-6494
- 11-digit product format
- 500906494
- Labeler code
- 50090
- Product ID
- 50090-6494_b74c0905-386e-43e9-b05a-cf6c7779ab77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212114
- Marketing category
- ANDA
- Marketing start
- 2019-07-26
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200; 300 mg/1; mg/1
- Pharmacologic classes
- 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], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G70B4ETF4S | EMTRICITABINE | 143491-57-0 | EMTRICITABINE |
| OTT9J7900I | TENOFOVIR DISOPROXIL FUMARATE | 202138-50-9 | TENOFOVIR DISOPROXIL FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6494-1 | 50090649401 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6494-1) | 2023-05-22 | No | No | Historical |