Active ingredient
Nevirapine
9 finished FDA listings contain Nevirapine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NEVIRAPINE, NEVIRAPINE HEMIHYDRATE
- Dosage forms
- Suspension, Tablet, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 200 mg/1 · 400 mg/1 · 50 mg/5ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 53654
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 078584 | HETERO LABS LTD III | 2012-05-22 | 1 |
| ANDA 077702 | AUROBINDO | 2012-05-22 | 1 |
| ANDA 078195 | STRIDES PHARMA | 2012-05-22 | 1 |
| ANDA 203080 | MICRO LABS LTD | 2012-05-22 | 1 |
| ANDA 077521 | AUROBINDO | 2012-05-22 | 1 |
| ANDA 202523 | MYLAN PHARMS INC | 2012-05-22 | 1 |
| ANDA 205651 | MYLAN | 2014-10-27 | 1 |
| ANDA 206879 | MACLEODS PHARMS | 2017-10-06 | 1 |
| ANDA 090688 | MACLEODS PHARMS | 2019-01-14 | 1 |
Official labeling on DailyMed
- NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.] · version 11 · 2026-08-07
- NEVIRAPINE (NEVIRAPINE) TABLET [MICRO LABS LIMITED] · version 13 · 2025-11-17
- NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] · version 10 · 2025-01-16
- NEVIRAPINE TABLET [AMNEAL PHARMACEUTICALS LLC] · version 10 · 2024-10-31
- NEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED] · version 12 · 2024-09-23
- NEVIRAPINE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] · version 6 · 2024-08-26
- NEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED] · version 9 · 2024-05-21
- NEVIRAPINE (NEVIRAPINE) TABLET [CAMBER PHARMACEUTICALS, INC.] · version 15 · 2022-08-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.