Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 70518-3077
- 11-digit product format
- 705183077
- Labeler code
- 70518
- Product ID
- 70518-3077_c5498de6-9201-23d6-e053-2a95a90add10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090513
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- Marketing end
- 0000-00-00
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200 mg/1; mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3077-0 | 70518307700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3077-0) | 2021-04-22 | 0000-00-00 | No | No | Current |
| 70518-3077-1 | 70518307701 | 4 TABLET, FILM COATED in 1 BLISTER PACK (70518-3077-1) | 2021-05-26 | 0000-00-00 | No | No | Current |
| 70518-3077-2 | 70518307702 | 3 TABLET, FILM COATED in 1 BLISTER PACK (70518-3077-2) | 2021-06-18 | 0000-00-00 | No | No | Current |