etravirine
- Product NDC
- 42291-473
- 11-digit product format
- 422910473
- Labeler code
- 42291
- Product ID
- 42291-473_48497b19-7665-4ce1-e063-6394a90ad69b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etravirine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA214196
- Marketing category
- ANDA
- Marketing start
- 2022-10-04
- Substance
- ETRAVIRINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- etravirine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETRAVIRINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0C50HW4FO1 |
| Rxcui | 754761, 1052658 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-473-12 | etravirine | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-473 | ETRAVIRINE TABLET [AVKARE] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_ea3856f6-fedf-ee88-e053-2a95a90a33ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-473-12 | 42291047312 | 120 TABLET in 1 BOTTLE (42291-473-12) | 120 tablet | 2022-10-04 | 0000-00-00 | No | No | Current |