etravirine
- Product NDC
- 60219-1720
- 11-digit product format
- 602191720
- Labeler code
- 60219
- Product ID
- 60219-1720_d93c4af1-6f7d-4744-8b1e-21d89a5f5c9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etravirine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA214196
- Marketing category
- ANDA
- Marketing start
- 2021-06-14
- Substance
- ETRAVIRINE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0C50HW4FO1 |
| Rxcui | 754761, 1052658, 1250721 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1720-7 | etravirine | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1720 | ETRAVIRINE TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231128_4e009f19-4609-4020-bee1-dc27c504046c.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 |
|---|
| 60219-1720-7 | 60219172007 | 120 TABLET in 1 BOTTLE, PLASTIC (60219-1720-7) | 120 tablet | 2021-06-14 | 0000-00-00 | No | No | Current |