NDC product
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
NDC 0378-5440 · Mylan Pharmaceuticals Inc.
Key facts
| Product NDC | 0378-5440 |
|---|---|
| Proprietary name | Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate |
| Nonproprietary name | Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate |
| Substances | EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR DISOPROXIL FUMARATE |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Labeler | Mylan Pharmaceuticals Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA208452 |
| Pharmacologic classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA] and 1 more |
| Marketing start | May 27, 2025 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: