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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.

ApplicationSponsorOriginal approvalListings
NDA 017963VALIDUS PHARMS1978-08-072
NDA 019962MELINTA THERAP1992-01-106
ANDA 074453ADAPTIS1995-04-272
ANDA 076704MYLAN2004-01-1622
ANDA 077761HIKMA FARMACEUTICA2007-05-305
ANDA 077739AUROBINDO PHARMA2007-09-1157
ANDA 078085HOSPIRA2008-04-295
ANDA 090317ONESOURCE SPECIALTY2010-04-191
ANDA 091045FRESENIUS KABI USA2010-10-253
ANDA 090617DR REDDYS LABS LTD2012-08-0133
ANDA 078889REDDYS2012-08-1529
ANDA 078950BAXTER HLTHCARE CORP2013-04-293
ANDA 202871ALEMBIC PHARMS LTD2013-05-2820
ANDA 204205GLAND2014-08-277
ANDA 200981RUBICON RESEARCH2014-10-28106
ANDA 204161ACTAVIS ELIZABETH2016-11-2510
NDA 210428SPIL2018-01-268
ANDA 204106NOVAST LABS2018-02-0622
ANDA 203894ZYDUS PHARMS2018-03-2326
ANDA 207465CIPLA2018-10-2612
ANDA 207206VISUM PHARM2018-12-1918
ANDA 205541HETERO LABS LTD III2020-11-066
ANDA 211143ALKEM LABS LTD2020-11-2534
ANDA 213854YICHANG HUMANWELL2021-02-1221
ANDA 216916GRANULES2023-06-1224
ANDA 216509GRANULES2023-08-074
ANDA 214110ZHEJIANG JUTAI PHARM2024-07-269
NDA 219373RUBICON RESEARCH2025-04-101
NDA 218698XTM CONSULTING2025-08-282

Official labeling on DailyMed

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.