FDA Orange Book · active-ingredient family
Labetalol hydrochloride
Labetalol hydrochloride: 5 brands, 27 generics; first approved Aug 01, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
27
Listed patents
0
Presentations
75
Brand (NDA) products
Originator applications
- LABETALOL HYDROCHLORIDERLDHIKMANDA 21333020226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/200ML (1MG/ML) SOLUTION INTRAVENOUS Rx — 100MG/100ML (1MG/ML) SOLUTION INTRAVENOUS Rx — 200MG/200ML (1MG/ML) SOLUTION INTRAVENOUS Rx — 300MG/300ML (1MG/ML) SOLUTION INTRAVENOUS Rx — 10MG/2ML (5MG/ML) SOLUTION INTRAVENOUS Discontinued — 20MG/4ML (5MG/ML) SOLUTION INTRAVENOUS Rx — - NORMODYNERLDSCHERINGNDA 01868719874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - TRANDATERLDSEBELA IRELAND LTDNDA 0194251985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - TRANDATERLDALVOGENNDA 01871619854 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - NORMODYNERLDSCHERINGNDA 0186861984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (27)
Abbreviated applications
- LABETALOL HYDROCHLORIDEAMNEALANDA 2188702025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 21794920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEUNICHEMANDA 21271920223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LABETALOL HYDROCHLORIDECAPLINANDA 2145332021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDERUBICON RESEARCHANDA 21195320213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEEPIC PHARMA LLCANDA 21299020203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDECADILA PHARMS LTDANDA 21132520193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEHIBROW HLTHCAREANDA 20786320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEAPPCOANDA 20960320184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEZYDUS PHARMSANDA 20774320173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEPH HEALTHANDA 20090820123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LABETALOL HYDROCHLORIDEGLAND PHARMA LTDANDA 0906992012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDEONESOURCE SPECIALTYANDA 0791342010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - LABETALOL HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 0760512002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDEAPOTHECONANDA 0753551999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - LABETALOL HYDROCHLORIDERSHOSPIRAANDA 0752391999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDERSHOSPIRAANDA 0752401999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDERISINGANDA 0754311999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDERISINGANDA 0755241999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - LABETALOL HYDROCHLORIDEHOSPIRAANDA 0752421999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - LABETALOL HYDROCHLORIDEINNOGENIXANDA 07521519993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEHIKMAANDA 0753031999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - LABETALOL HYDROCHLORIDEAPOTHECONANDA 07522319983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LABETALOL HYDROCHLORIDETEVAANDA 07498919983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LABETALOL HYDROCHLORIDEAIPING PHARM INCANDA 07511319983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEHERITAGE PHARMAANDA 07478719984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - LABETALOL HYDROCHLORIDEWATSON LABSANDA 07513319983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
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
42 yr 10 mo ago
Most recent approval
7 mo ago
Approvals span 1984–2026 across 32 FDA applications.
Brand (NDA) 516%
Generic (ANDA) 2784%
Labetalol hydrochloride: 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
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- 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.
