Emtricitabine and tenofovir disoproxil fumarate
- Product NDC
- 68071-3831
- 11-digit product format
- 680713831
- Labeler code
- 68071
- Product ID
- 68071-3831_331490f0-d346-1ca0-e063-6394a90a8598
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA201806
- Marketing category
- ANDA
- Marketing start
- 2021-10-07
- 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 |
|---|
| 68071-3831-3 | 68071383103 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-3831-3) | 2025-04-18 | No | No | Historical |