Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
- Product NDC
- 42385-928
- 11-digit product format
- 423850928
- Labeler code
- 42385
- Product ID
- 42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA212786
- Marketing category
- ANDA
- Marketing start
- 2020-05-14
- 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
- Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-928-30 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 42385-928-90 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-928 | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231116_1f8f9fe1-b8fd-4f65-8832-9d3d6802d076.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 |
|---|
| 42385-928-30 | 42385092830 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30) | 2020-05-14 | 0000-00-00 | No | No | Current |
| 42385-928-90 | 42385092890 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) | 2020-05-14 | 0000-00-00 | No | No | Current |