Active ingredient
Venlafaxine
338 finished FDA listings contain Venlafaxine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VENLAFAXINE BESYLATE MONOHYDRATE, VENLAFAXINE HYDROCHLORIDE
- Dosage forms
- Capsule, Extended Release, Tablet, Tablet, Coated, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 65
- Strengths listed
- 100 mg/1 · 112.5 mg/1 · 150 mg/1 · 225 mg/1 · 25 mg/1 · 37.5 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Effexor Xr, Venlafaxine, Venlafaxine Hcl Er, Venlafaxine Hydrochloride, Venlafaxine Hydrochloride Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 39786
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 020699 | UPJOHN | 1997-10-20 | 3 |
| ANDA 076690 | TEVA | 2006-08-03 | 6 |
| NDA 022104 | OSMOTICA PHARM US | 2008-05-20 | 3 |
| ANDA 078627 | SUN PHARM INDS INC | 2008-06-13 | 12 |
| ANDA 077653 | ZYDUS PHARMS USA | 2008-06-13 | 28 |
| ANDA 078301 | DR REDDYS LABS LTD | 2008-06-13 | 5 |
| ANDA 078554 | HERITAGE | 2009-01-09 | 5 |
| ANDA 090555 | AUROBINDO PHARMA | 2010-04-07 | 21 |
| ANDA 076565 | TEVA | 2010-06-28 | 11 |
| ANDA 091272 | SUN PHARM | 2010-08-18 | 4 |
| ANDA 078932 | ALEMBIC PHARMS LTD | 2010-12-14 | 23 |
| ANDA 200834 | AUROBINDO PHARMA LTD | 2011-04-14 | 50 |
| ANDA 090174 | ZYDUS PHARMS USA INC | 2011-04-14 | 17 |
| ANDA 078421 | DR REDDYS LABS LTD | 2011-05-06 | 6 |
| ANDA 202036 | YAOPHARMA CO LTD | 2015-05-28 | 5 |
| ANDA 205468 | MPP PHARMA | 2017-03-24 | 2 |
| ANDA 204889 | MACLEODS PHARMS | 2017-10-05 | 3 |
| ANDA 206250 | CADILA PHARMS LTD | 2018-11-21 | 5 |
| ANDA 201272 | PLATINUM | 2018-11-23 | 3 |
| ANDA 212277 | ANNORA PHARMA | 2019-07-08 | 22 |
| ANDA 211323 | CADILA PHARMS LTD | 2019-08-29 | 9 |
| ANDA 209193 | ADAPTIS | 2019-10-31 | 3 |
| ANDA 203332 | ADAPTIS | 2020-03-12 | 4 |
| ANDA 214419 | ASCENT PHARMS INC | 2020-10-21 | 12 |
| ANDA 214127 | ALKEM LABS LTD | 2021-06-10 | 6 |
| ANDA 214609 | SOMERSET THERAPS LLC | 2021-06-30 | 2 |
| ANDA 214654 | YICHANG HUMANWELL | 2021-08-06 | 25 |
| NDA 215429 | ALMATICA | 2022-06-29 | 1 |
| ANDA 215622 | ZYDUS PHARMS | 2022-08-30 | 9 |
| ANDA 216044 | UNIQUE | 2022-11-28 | 6 |
| ANDA 214691 | AJANTA PHARMA LTD | 2023-04-12 | 4 |
| ANDA 217390 | GRANULES | 2023-05-18 | 14 |
| ANDA 217767 | ALEMBIC | 2024-06-06 | 9 |
Official labeling on DailyMed
- VENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] · version 5 · 2026-09-22
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 4 · 2026-09-07
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 4 · 2026-08-31
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 4 · 2026-08-31
- VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 3 · 2026-08-31
- VENLAFAXINE TABLET [REMEDYREPACK INC.] · version 3 · 2026-08-31
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ADVAGEN PHARMA LTD.] · version 4 · 2026-08-26
- VENLAFAXINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 8 · 2026-08-19
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] · version 9 · 2026-08-03
- VENLAFAXINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] · version 4 · 2026-07-31
- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] · version 2 · 2026-07-31
- VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.] · version 13 · 2026-07-29
Showing the 12 most recent of 184 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.