EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Product NDC
- 68180-287
- 11-digit product format
- 681800287
- Labeler code
- 68180
- Product ID
- 68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204131
- Marketing category
- ANDA
- Marketing start
- 2021-06-23
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-287-01 | 68180028701 | 100 TABLET, FILM COATED in 1 BOTTLE (68180-287-01) | 2021-06-23 | 0000-00-00 | No | No | Current |
| 68180-287-06 | 68180028706 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-287-06) | 2021-06-23 | 0000-00-00 | No | No | Current |