FDA Orange Book · active-ingredient family
Metoprolol tartrate
Metoprolol tartrate: 4 brands, 33 generics; first approved Mar 30, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 33 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
33
Listed patents
0
Presentations
69
Brand (NDA) products
Originator applications
- XTM CONSULTINGNDA 2186982025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx — - RUBICON RESEARCHNDA 2193732025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx — - LOPRESSORRLDNOVARTISNDA 0187041984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - LOPRESSORRLDVALIDUS PHARMSNDA 017963—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Generic (ANDA) products (33)
Abbreviated applications
- METOPROLOL TARTRATEZYDUS PHARMSANDA 21240220233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATESCIEGEN PHARMSANDA 20895520203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - METOPROLOL TARTRATERUBICON RESEARCHANDA 20098120145 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 37.5MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - METOPROLOL TARTRATEGLANDANDA 2042052014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATEALEMBIC PHARMS LTDANDA 20287120133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - METOPROLOL TARTRATEBAXTER HLTHCARE CORPANDA 0789502013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATELUITPOLDANDA 0913072010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATEFRESENIUS KABI USAANDA 0910452010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATEONESOURCE SPECIALTYANDA 0903172010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATEAM REGENTANDA 0903862009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATESUN PHARM INDUSTRIESANDA 07365420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEIPCA LABS LTDANDA 07845920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - METOPROLOL TARTRATERSHOSPIRAANDA 0780852008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATESANDOZANDA 0773602007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATEAUROBINDO PHARMAANDA 07773920075 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 37.5MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - METOPROLOL TARTRATEHIKMA FARMACEUTICAANDA 0777612007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATEMYLANANDA 07670420045 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 37.5MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - METOPROLOL TARTRATESUN PHARM INDS INCANDA 0766702004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEHIKMAANDA 0764952003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - METOPROLOL TARTRATEHOSPIRAANDA 0751601998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATESUN PHARM INDS INCANDA 07464419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - METOPROLOL TARTRATERENATAANDA 07445319952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - METOPROLOL TARTRATEHERITAGE PHARMAANDA 07414119952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATETEVAANDA 07414319942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEPUREPAC PHARMANDA 07438019942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEWATSON LABSANDA 07421719942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATECHARTWELL RXANDA 0732881994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - METOPROLOL TARTRATECHARTWELL RXANDA 0732891994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEAPOTHECONANDA 07425819942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATETEVA PHARMSANDA 07433319942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - METOPROLOL TARTRATEHOSPIRAANDA 0741331993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATEWATSON LABSANDA 0740321993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - METOPROLOL TARTRATEPHARMOBEDIENTANDA 07366619932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
43 yr 2 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 1984–2025 across 37 FDA applications.
Brand (NDA) 411%
Generic (ANDA) 3389%
Metoprolol tartrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
