Active ingredient
Metoprolol
498 finished FDA listings contain Metoprolol as their only active ingredient; 14 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- METOPROLOL SUCCINATE, METOPROLOL TARTRATE
- Dosage forms
- Capsule, Extended Release, Injection, Injection, Solution, Solution, Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 82
- Strengths listed
- 1 mg/ml · 10 mg/ml · 100 mg/1 · 12.5 mg/1 · 200 mg/1 · 25 mg/1 · 37.5 mg/1 · 5 mg/5ml · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Kapspargo, Lopressor, Metoprolol, Metoprolol Succinate, Metoprolol Succinate Er, Metoprolol Tartrate, Toprol Xl
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6918
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 017963 | VALIDUS PHARMS | 1978-08-07 | 2 |
| NDA 019962 | MELINTA THERAP | 1992-01-10 | 6 |
| ANDA 074453 | ADAPTIS | 1995-04-27 | 2 |
| ANDA 076704 | MYLAN | 2004-01-16 | 22 |
| ANDA 077761 | HIKMA FARMACEUTICA | 2007-05-30 | 5 |
| ANDA 077739 | AUROBINDO PHARMA | 2007-09-11 | 57 |
| ANDA 078085 | HOSPIRA | 2008-04-29 | 5 |
| ANDA 090317 | ONESOURCE SPECIALTY | 2010-04-19 | 1 |
| ANDA 091045 | FRESENIUS KABI USA | 2010-10-25 | 3 |
| ANDA 090617 | DR REDDYS LABS LTD | 2012-08-01 | 33 |
| ANDA 078889 | REDDYS | 2012-08-15 | 29 |
| ANDA 078950 | BAXTER HLTHCARE CORP | 2013-04-29 | 3 |
| ANDA 202871 | ALEMBIC PHARMS LTD | 2013-05-28 | 20 |
| ANDA 204205 | GLAND | 2014-08-27 | 7 |
| ANDA 200981 | RUBICON RESEARCH | 2014-10-28 | 106 |
| ANDA 204161 | ACTAVIS ELIZABETH | 2016-11-25 | 10 |
| NDA 210428 | SPIL | 2018-01-26 | 8 |
| ANDA 204106 | NOVAST LABS | 2018-02-06 | 22 |
| ANDA 203894 | ZYDUS PHARMS | 2018-03-23 | 26 |
| ANDA 207465 | CIPLA | 2018-10-26 | 12 |
| ANDA 207206 | VISUM PHARM | 2018-12-19 | 18 |
| ANDA 205541 | HETERO LABS LTD III | 2020-11-06 | 6 |
| ANDA 211143 | ALKEM LABS LTD | 2020-11-25 | 34 |
| ANDA 213854 | YICHANG HUMANWELL | 2021-02-12 | 21 |
| ANDA 216916 | GRANULES | 2023-06-12 | 24 |
| ANDA 216509 | GRANULES | 2023-08-07 | 4 |
| ANDA 214110 | ZHEJIANG JUTAI PHARM | 2024-07-26 | 9 |
| NDA 219373 | RUBICON RESEARCH | 2025-04-10 | 1 |
| NDA 218698 | XTM CONSULTING | 2025-08-28 | 2 |
Official labeling on DailyMed
- METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] · version 2 · 2026-09-18
- METOPROLOL TARTRATE TABLET [REMEDYREPACK INC.] · version 1 · 2026-09-11
- METOPROLOL TARTRATE TABLET [REMEDYREPACK INC.] · version 5 · 2026-09-07
- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [GRANULES INDIA LTD] · version 3 · 2026-09-07
- METOPROLOL TARTRATE (METOPROLOL) TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 4 · 2026-09-07
- METOPROLOL TARTRATE TABLET [PROFICIENT RX LP] · version 1 · 2026-09-07
- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 5 · 2026-09-02
- METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [REDPHARM DRUG] · version 1 · 2026-09-02
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] · version 7 · 2026-09-02
- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 11 · 2026-08-31
- METOPROLOL TARTRATE (METOPROLOL) TABLET [REDPHARM DRUG] · version 1 · 2026-08-27
- METOPROLOL TARTRATE TABLET [REDPHARM DRUG] · version 1 · 2026-08-27
Showing the 12 most recent of 347 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.