SYMFI
- Product NDC
- 49502-475
- 11-digit product format
- 495020475
- Labeler code
- 49502
- Product ID
- 49502-475_0a09befe-6075-4bef-bd45-0e41082559d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA022142
- Marketing category
- NDA
- Marketing start
- 2018-04-25
- Substance
- EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 600; 300; 300 mg/1; mg/1; mg/1
- Pharmacologic classes
- Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SYMFI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFAVIRENZ | 600 mg/1 |
| LAMIVUDINE | 300 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JE6H2O27P8, 2T8Q726O95, OTT9J7900I |
| Rxcui | 864661, 2043464 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49502-475-77 | SYMFI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 49502-475-77 | SYMFI | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
| 49502-475-93 | SYMFI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 49502-475-93 | SYMFI | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49502-475 | SYMFI (EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250212_81a55dd9-78a8-49c3-88ab-8f5bffafa359.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49502-475-77 | 49502047577 | 1 in 1 CARTON | | | | | Historical |
| 49502-475-93 | 49502047593 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2018-04-25 | 0000-00-00 | No | No | Current |