Efavirenz
- Product NDC
- 65862-106
- 11-digit product format
- 658620106
- Labeler code
- 65862
- Product ID
- 65862-106_a02dd4c8-6159-48b0-a79c-c362f1f4daf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Efavirenz
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078064
- Marketing category
- ANDA
- Marketing start
- 2017-12-15
- Substance
- EFAVIRENZ
- Active strength
- 200 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], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase 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
- Efavirenz
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFAVIRENZ | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JE6H2O27P8 |
| Rxcui | 205290, 205291, 205292 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-106 | EFAVIRENZ CAPSULE [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240104_4c57ad7f-321a-46c8-851a-c895466eb8e1.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 |
|---|
| 65862-106-09 | 65862010609 | 9 BLISTER PACK in 1 CARTON (65862-106-09) / 10 CAPSULE in 1 BLISTER PACK | 9 blister pack | 2017-12-15 | 0000-00-00 | No | No | Current |
| 65862-106-10 | 65862010610 | 3 BLISTER PACK in 1 CARTON (65862-106-10) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2017-12-15 | 0000-00-00 | No | No | Current |
| 65862-106-15 | 65862010615 | 1500 CAPSULE in 1 BAG (65862-106-15) | 1500 capsule | 15-DEC-17 | | | | Current |
| 65862-106-30 | 65862010630 | 30 CAPSULE in 1 BOTTLE (65862-106-30) | 30 capsule | 2017-12-15 | 0000-00-00 | No | No | Current |
| 65862-106-90 | 65862010690 | 90 CAPSULE in 1 BOTTLE (65862-106-90) | 90 capsule | 2017-12-15 | 0000-00-00 | No | No | Current |