FDA Orange Book · active-ingredient family
Loperamide hydrochloride
Loperamide hydrochloride: 7 brands, 31 generics; first approved Jul 31, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 31 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
31
Listed patents
0
Presentations
40
Brand (NDA) products
Originator applications
- LOPERAMIDE HYDROCHLORIDERLDBIONPHARMANDA 02185520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL OTC — 2MG CAPSULE ORAL OTC — - J AND J CONSUMER INCNDA 0204481997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET, CHEWABLE ORAL Discontinued — - KENVUE BRANDSNDA 0198601989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - IMODIUM A-DRLDKENVUE BRANDSNDA 01948719882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — 1MG/7.5ML SOLUTION ORAL OTC — - IMODIUMRLDJ AND J CONSUMER INCNDA 017694—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Discontinued — - JANSSEN PHARMSNDA 0190371984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - J AND J CONSUMER INCNDA 017690—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (31)
Abbreviated applications
- LOPERAMIDE HYDROCHLORIDEAUROBINDO PHARMAANDA 2203722025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL OTC — - LOPERAMIDE HYDROCHLORIDEMARKSANS PHARMAANDA 2201532025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - LOPERAMIDE HYDROCHLORIDEBIONPHARMAANDA 2201002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/7.5ML SOLUTION ORAL OTC — - LOPERAMIDE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2181222023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEJUBILANT CADISTAANDA 2178402023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 2174712023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDERUBICON RESEARCHANDA 2168762023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEBIONPHARMAANDA 2155792021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEEDENBRIDGE PHARMSANDA 2150012021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEONESOURCEANDA 2130702021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL OTC — - LOPERAMIDE HYDROCHLORIDEAUROBINDO PHARMAANDA 2065482015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - LOPERAMIDE HYDROCHLORIDEPERRIGO R AND DANDA 0912922011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/7.5ML SOLUTION ORAL OTC — - LOPERAMIDE HYDROCHLORIDELNKANDA 0764972003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - LOPERAMIDE HYDROCHLORIDEL PERRIGO COANDA 0752322000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - LOPERAMIDE HYDROCHLORIDEDURAMED PHARMS BARRANDA 0749911997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEWOCKHARDT BIO AGANDA 0747301997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEPAI HOLDINGSANDA 0743521995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDETEVAANDA 0734781995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEABLEANDA 0735281993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDECONTRACT PHARMACALANDA 0732541993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEWATSON LABSANDA 0730621993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEOHM LABSANDA 0740911992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL OTC — - LOPERAMIDE HYDROCHLORIDEPERRIGOANDA 0741941992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEALPHARMA US PHARMSANDA 0731871992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDECHARTWELL RXANDA 0729931992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDETEVAANDA 0731921992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDEALLIEDANDA 0730791992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEPERRIGOANDA 0732431992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDEROXANEANDA 0730801991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Discontinued — - LOPERAMIDE HYDROCHLORIDERSMYLANANDA 0727411991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE ORAL Rx AB - LOPERAMIDE HYDROCHLORIDETEVAANDA 0731221991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG CAPSULE 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
42 yr 10 mo ago
Most recent approval
9 mo ago
Approvals span 1984–2025 across 38 FDA applications.
Brand (NDA) 718%
Generic (ANDA) 3182%
Loperamide 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
- 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.
