FDA Orange Book · active-ingredient family
Bethanechol chloride
Bethanechol chloride: 1 brand, 52 generics; first approved Jun 08, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 52 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
52
Listed patents
0
Presentations
77
Brand (NDA) products
Originator applications
- URECHOLINERLDTEVA BRANDED PHARMNDA 006536—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued —
Generic (ANDA) products (52)
Abbreviated applications
- BETHANECHOL CHLORIDEHERITAGE PHARMAANDA 09125620104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDESUN PHARM INDS INCANDA 04089720094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDELANNETT CO INCANDA 04067720084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDERSAMNEAL PHARMANDA 04085520074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDECHARTWELL RXANDA 04072820074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDEIMPAX LABSANDA 04072120064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 0406332005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 0406342005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 0406352005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 0406362005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 0405522004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 0405532004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 0405542004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 0405512004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEABLEANDA 0404922004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEABLEANDA 0404832004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEABLEANDA 0404852004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEABLEANDA 0405092004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWOCKHARDTANDA 0405322003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWOCKHARDTANDA 0405332003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWOCKHARDTANDA 0405342003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWOCKHARDTANDA 0405182003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - ODYSSEY PHARMSANDA 0890951985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - ODYSSEY PHARMSANDA 0890961985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - URECHOLINERLDODYSSEY PHARMSANDA 0884401984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - URECHOLINERLDODYSSEY PHARMSANDA 0884411984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEASCOTANDA 0882881983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEASCOTANDA 0882891983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEIVAX SUB TEVA PHARMSANDA 084689—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDELANNETTANDA 084702—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDELANNETTANDA 084712—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDELANNETTANDA 084074—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDESANDOZANDA 084353—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDESANDOZANDA 084378—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDESANDOZANDA 084379—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDESANDOZANDA 084383—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDESANDOZANDA 084384—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 084402—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085230—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085841—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 084408—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085228—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085842—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 084441—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085229—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 085839—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 087397—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BETHANECHOL CHLORIDEWATSON LABSANDA 087444—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHARTWELL RXANDA 086262—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA - CHARTWELL RXANDA 086263—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - CHARTWELL RXANDA 085882—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - GLENWOODANDA 084188—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 25MG 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 10 mo ago
Most recent approval
16 yr 6 mo ago
Approvals span 1983–2010 across 53 FDA applications.
Brand (NDA) 12%
Generic (ANDA) 5298%
Bethanechol chloride: 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.
