emtricitabine, rilpivirine and tenofovir disoproxil fumarate
- Product NDC
- 42385-801
- 11-digit product format
- 423850801
- Labeler code
- 42385
- Product ID
- 42385-801_7193c90e-456c-4cfb-8181-65a1618dae51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine, rilpivirine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA220232
- Marketing category
- ANDA
- Marketing start
- 2026-03-05
- Substance
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200; 25; 300 mg/1; mg/1; mg/1
- 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], 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], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- emtricitabine, rilpivirine and tenofovir disoproxil fumarate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EMTRICITABINE | 200 mg/1 |
| RILPIVIRINE HYDROCHLORIDE | 25 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G70B4ETF4S, 212WAX8KDD, OTT9J7900I |
| Rxcui | 1147334 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-801-30 | emtricitabine, rilpivirine and tenofovir disoproxil fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42385-801-30 | 42385080130 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-801-30) | 2026-03-05 | No | No | Current |