Active ingredient
Valsartan
140 finished FDA listings contain Valsartan as their only active ingredient; 275 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- VALSARTAN
- Dosage forms
- Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 36
- Strengths listed
- 160 mg/1 · 320 mg/1 · 4 mg/ml · 40 mg/1 · 80 mg/1
- Brand names in FDA listings
- Diovan, Valsartan
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 69749
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 |
|---|---|---|---|
| NDA 021283 | NOVARTIS | 2001-07-18 | 7 |
| ANDA 077492 | OHM LABS INC | 2014-06-26 | 4 |
| ANDA 201677 | LUPIN | 2015-01-05 | 1 |
| ANDA 203536 | JUBILANT GENERICS | 2015-01-05 | 9 |
| ANDA 091367 | ALEMBIC | 2015-01-05 | 8 |
| ANDA 090866 | MYLAN | 2015-01-05 | 5 |
| ANDA 202223 | AUROBINDO PHARMA LTD | 2015-01-05 | 4 |
| ANDA 203311 | HETERO LABS LTD V | 2015-01-05 | 24 |
| ANDA 204821 | PRINSTON INC | 2015-06-09 | 12 |
| ANDA 204011 | AMNEAL PHARMS | 2016-01-11 | 14 |
| ANDA 202696 | MACLEODS PHARMS LTD | 2016-09-16 | 8 |
| NDA 209139 | CARMEL BIOSCIENCES | 2017-12-19 | 1 |
| ANDA 205347 | ADAPTIS | 2018-04-09 | 4 |
| ANDA 209261 | UNICHEM | 2018-05-04 | 4 |
| ANDA 205536 | ALKEM LABS LTD | 2019-03-12 | 11 |
| ANDA 201618 | DR REDDYS | 2021-10-05 | 4 |
| ANDA 204038 | SCIEGEN PHARMS | 2021-10-27 | 4 |
| ANDA 214102 | NOVITIUM PHARMA | 2021-11-02 | 2 |
| ANDA 218991 | ZYDUS LIFESCIENCES | 2024-07-22 | 9 |
| ANDA 216460 | RUBICON RESEARCH | 2025-06-05 | 1 |
| ANDA 218897 | PHARMOBEDIENT | 2026-04-21 | 4 |
Official labeling on DailyMed
- VALSARTAN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-09-04
- VALSARTAN TABLET VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.] · version 12 · 2026-08-28
- VALSARTAN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-08-27
- DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] · version 32 · 2026-08-13
- VALSARTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 9 · 2026-08-07
- VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.] · version 11 · 2026-08-07
- VALSARTAN TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2026-08-07
- VALSARTAN TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-08-06
- VALSARTAN TABLET [SCIEGEN PHARMACEUTICALS, INC.] · version 3 · 2026-08-03
- VALSARTAN TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · version 5 · 2026-07-15
- VALSARTAN TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · version 3 · 2026-07-15
- VALSARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 10 · 2026-07-15
Showing the 12 most recent of 63 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.