FDA Orange Book · active-ingredient family
Dicyclomine hydrochloride
Dicyclomine hydrochloride: 3 brands, 42 generics; first approved Oct 15, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 42 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
42
Listed patents
0
Presentations
48
Brand (NDA) products
Originator applications
- BENTYLRLDALLERGANNDA 00740919842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — - BENTYLRLDABBVIENDA 00837019842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 10MG/ML INJECTABLE INJECTION Discontinued — - BENTYLRLDAPTALIS PHARMA USNDA 0079611984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued —
Generic (ANDA) products (42)
Abbreviated applications
- DICYCLOMINE HYDROCHLORIDERISINGANDA 2192422025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEPRINSTON INCANDA 2183102025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDERISINGANDA 2189522024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2143322024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2143332024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDEANNORA PHARMAANDA 2180182024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEANNORA PHARMAANDA 2175662024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEPRINSTON INCANDA 2175312023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEBIONPHARMAANDA 2179162023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDETWI PHARMSANDA 2167822023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDECOREPHARMAANDA 2166392023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDETWI PHARMSANDA 2170542022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDERUBICON RESEARCHANDA 21673620222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx — - DICYCLOMINE HYDROCHLORIDECOREPHARMAANDA 2167602022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDENOVITIUM PHARMAANDA 2147212021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Rx AA - DICYCLOMINE HYDROCHLORIDEHIKMAANDA 2122862020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Rx AA - DICYCLOMINE HYDROCHLORIDEPRAXGEN PHARMSANDA 2120582019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - DICYCLOMINE HYDROCHLORIDEHIKMAANDA 2107882019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - DICYCLOMINE HYDROCHLORIDENEXUSANDA 2064682019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - DICYCLOMINE HYDROCHLORIDEFRESENIUS KABI USAANDA 2102572019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDESLATE RUN PHARMAANDA 2070762018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDERSFOSUN PHARMAANDA 2109792018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDERENEW PHARMSANDA 2070842018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - DICYCLOMINE HYDROCHLORIDEAM REGENTANDA 2083532017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDERSPH HEALTHANDA 0401692005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Rx AA - HIKMAANDA 0404652003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - DICYCLOMINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 0403191999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 0403171999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDELANNETTANDA 0402301999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEWEST WARDANDA 0402041997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEHIKMA PHARMSANDA 0401611996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEPIONEER PHARMSANDA 0893611989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0845051986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDEPIONEER PHARMSANDA 0885851986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDERSWATSON LABSANDA 0852231986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 0850821986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 0831791986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDEDR REDDYSANDA 0806141986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 0843611986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0846001985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - DICYCLOMINE HYDROCHLORIDERSLANNETTANDA 084285—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - DICYCLOMINE HYDROCHLORIDEALPHARMA US PHARMSANDA 084479—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP 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 6 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 1984–2025 across 45 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 4293%
Dicyclomine 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.
