Efavirenz is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Efavirenz.
| Product ID | 65862-049_9190a300-f586-49f9-a4b2-50faceb690e4 |
| NDC | 65862-049 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Efavirenz |
| Generic Name | Efavirenz |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-09-21 |
| Marketing Category | ANDA / DRUG FOR FURTHER PROCESSING |
| Application Number | ANDA077673 |
| Labeler Name | Aurobindo Pharma Limited |
| Substance Name | EFAVIRENZ |
| Active Ingredient Strength | 600 mg/1 |
| Pharm Classes | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-09-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077673 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-21 |
| Marketing Category | ANDA |
| Application Number | ANDA077673 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-21 |
| Ingredient | Strength |
|---|---|
| EFAVIRENZ | 600 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-2233 | Efavirenz | efavirenz |
| 31722-504 | Efavirenz | Efavirenz |
| 42543-889 | Efavirenz | Efavirenz |
| 51407-382 | Efavirenz | Efavirenz |
| 64380-889 | Efavirenz | Efavirenz |
| 64980-406 | Efavirenz | Efavirenz |
| 64980-407 | Efavirenz | Efavirenz |
| 65862-049 | Efavirenz | Efavirenz |
| 65862-104 | Efavirenz | Efavirenz |
| 69097-301 | Efavirenz | Efavirenz |
| 70518-1100 | Efavirenz | Efavirenz |
| 70518-1013 | Efavirenz | Efavirenz |
| 65862-105 | Efavirenz | Efavirenz |
| 65862-106 | Efavirenz | Efavirenz |
| 65862-774 | Efavirenz | Efavirenz |
| 0056-0470 | SUSTIVA | Efavirenz |
| 0056-0474 | SUSTIVA | efavirenz |
| 0056-0510 | SUSTIVA | efavirenz |