Active ingredient
Efavirenz
8 finished FDA listings contain Efavirenz as their only active ingredient; 10 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- EFAVIRENZ
- Dosage forms
- Capsule, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1 · 200 mg/1 · 50 mg/1 · 600 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 195085
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 078064 | AUROBINDO PHARMA | 2017-12-15 | 3 |
| ANDA 078886 | HETERO LABS LTD III | 2018-04-27 | 2 |
| ANDA 204766 | CIPLA | 2018-06-15 | 1 |
| ANDA 077673 | AUROBINDO PHARMA LTD | 2018-09-21 | 1 |
| ANDA 091579 | MACLEODS PHARMS | 2024-05-10 | 1 |
Official labeling on DailyMed
- EFAVIRENZ TABLET, FILM COATED [CIPLA USA INC.] · version 7 · 2024-09-10
- EFAVIRENZ TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2024-07-01
- EFAVIRENZ CAPSULE [AUROBINDO PHARMA LIMITED] · version 7 · 2024-01-04
- EFAVIRENZ TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 10 · 2024-01-04
- EFAVIRENZ (EFAVIRENZ) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2023-05-17
- EFAVIRENZ (EFAVIRENZ) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.] · version 2 · 2023-01-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.