ETRAVIRINE
- Product NDC
- 69315-286
- 11-digit product format
- 693150286
- Labeler code
- 69315
- Product ID
- 69315-286_f356d1ba-3572-4a79-9846-94ee2030f04b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ETRAVIRINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA215402
- Marketing category
- ANDA
- Marketing start
- 2022-06-05
- Substance
- ETRAVIRINE
- Active strength
- 200 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ETRAVIRINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETRAVIRINE | 200 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 |
|---|
| 69315-286-06 | ETRAVIRINE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-286 | ETRAVIRINE TABLET [LEADING PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_48ffeac8-38e8-4007-903a-dbffce25d679.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 |
|---|
| 69315-286-06 | 69315028606 | 60 TABLET in 1 BOTTLE (69315-286-06) | 60 tablet | 2022-06-05 | 0000-00-00 | No | No | Current |