Dicyclomine Oral Capsule

Brand(s)
Bentyl
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aptalis Pharma Inc. (2013-06-18)
Oldest Current Product
1950-05-11
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\DICYCLOMINE
FDAOB
ORAL\CAPSULE\DICYCLOMINE HYDROCHLORIDE
ORAL\TABLET\DICYCLOMINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\DICYCLOMINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\DICYCLOMINE

product(s) by strength(s)

dicyclomine hydrochloride 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1589140012BentylNDAAptalis Pharma Inc.1950-05-11DICYCLOMINE HYDROCHLORIDEORALCAPSULENDA007409c56598d5-9cd1-4cce-b172-ac338775aec7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781610ANDAMylan Pharmaceuticals Inc.2013-03-27DICYCLOMINE HYDROCHLORIDEORALCAPSULEANDA040319ac145b81-5f26-4914-b47f-6c4958e94146
2005270586ANDALannett Company, Inc.1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULEANDA084285bd2cba10-70ec-4d1f-b46c-53d1de2ee130
3005910794ANDAWatson Laboratories, Inc.1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULEANDA085082a5937c7b-cdfc-46e6-a0fa-541b24f91d47

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001433126ANDAWest-Ward Pharmaceutical Corp1997-02-28DICYCLOMINE HYDROCHLORIDEORALCAPSULEANDA0402045a553bda-1e3d-4b80-913f-73dd54655033
2006150327ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1997-02-28DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204b8c72fd8-6030-4c0a-80a6-d36cf698a576
3165900077ANDAStat Rx Usa Llc1997-02-28DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204ddc61a17-0577-47dc-b323-05e2594a09e6
4216950218ANDARebel Distributors Corp1997-02-28DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204da10031f-9da8-49a2-a019-5ce80c4b7ede
5538080611ANDAState Of Florida Doh Central Pharmacy2009-07-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204c2aac506-3f10-4116-9b65-6341aaaf9893
6538081055ANDAState Of Florida Doh Central Pharmacy2013-01-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA04020488942e82-b798-4122-9ea2-0932ef09357f
7604290155ANDAGolden State Medical Supply, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040161150078be-0792-4053-b6d3-641cae923b09
8636293341ANDABryant Ranch Prepack1997-02-28DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204c8a3893f-612c-4a03-b3de-6caaff80d52b
9687889935ANDAPreferred Pharmaceuticals, Inc.2012-01-17DICYCLOMINE HYDROCHLORIDEORALCAPSULE001433126ANDA040204fcca6fd5-6a67-4bb9-b9f2-634c87b8cc31

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004407384ANDALiberty Pharmaceuticals, Inc.1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA08428559b4c00d-74cd-44a6-a76c-d44e93bbeca9
2006157754ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA08508283484c6b-08e3-4002-a5b4-c9877c03f3a8
3332610963ANDAAidarex Pharmaceuticals Llc1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285d9daced1-c2e0-47c3-b590-c77f3da94e88
4422540057ANDARebel Distributors Corp1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA0850825cc4daa2-f108-4672-9dd8-06c3785bed28
5430630112ANDAPd-Rx Pharmaceuticals, Inc.1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA0850828c29140b-e181-4807-870f-28e315c6d4c4
6430630629ANDAPd-Rx Pharmaceuticals, Inc.1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA08508287cd2a04-54d6-4022-b365-646692a42f56
7493490082ANDARemedyrepack Inc.2010-11-20DICYCLOMINE HYDROCHLORIDEORALCAPSULE059107940ANDA085082bf9f9a6c-d2af-4832-b101-a2499a898413
8499990291ANDALake Erie Medical Dba Quality Care Products Llc1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285afdf69a7-6409-4894-b1a8-2e2f99ff021d
9500900126ANDAA-S Medication Solutions Llc1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285b3c9dc85-2c6c-44f0-9c98-02673af934cb
10500900127ANDAA-S Medication Solutions Llc1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA0842855f5d7145-118b-4cab-bfe0-19f7740ef1fe
11500900128ANDAA-S Medication Solutions Llc1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA0850828b242ad1-0438-42ed-931b-8f85ea9bc660
12500900129ANDAA-S Medication Solutions Llc1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082820d2d23-34ce-439a-8130-49d9a93c0283
13504363367ANDAUnit Dose Services1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285bfefe3d2-990d-4ef4-8ce9-addc24e29fa9
14510790118ANDAMylan Institutional Inc.1999-12-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE003781610ANDA040319d2c074e8-9ee2-4bbf-a0a4-6aeba4ad9d50
15521250058ANDARemedyrepack Inc.2013-03-09, 2013-05-29, 2014-08-27DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285695888d3-135d-49b4-9327-8c9ec83c343f, 81e1264b-6e5f-4d0e-a714-fae75bd270e4, 9cdf9530-8750-4651-9018-1f2ddc8f9aa4
16521250391ANDARemedyrepack Inc.2013-05-14DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285cd19dd27-d52c-41bf-8836-407c5172beb2
17521250651ANDARemedyrepack Inc.2013-07-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE003781610ANDA0403194282ea80-21db-4fd6-9a78-cc06b67b7df3
18521250745ANDARemedyrepack Inc.2013-10-15, 2014-02-20DICYCLOMINE HYDROCHLORIDEORALCAPSULE003781610ANDA04031952c8422d-ce70-42bb-9d5b-8b5956239ffd, b9546f1f-e672-4cb9-a17e-b236fc50c2a8
19538080233ANDAState Of Florida Doh Central Pharmacy2009-07-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082f325dd3d-8ebe-4aa3-8c45-43438c75defe
20545690417ANDAA-S Medication Solutions Llc1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082d59bd885-a123-48fc-811e-01f0d976220a
21548680033ANDAPhysicians Total Care, Inc.1995-10-26DICYCLOMINE HYDROCHLORIDEORALCAPSULE00527058601ANDA08428554582bac-9386-4070-bfce-8c392172d24d
22551545599ANDACardinal Health2011-08-16DICYCLOMINE HYDROCHLORIDEORALCAPSULE510790118ANDA040319399ff144-aeaa-4d9b-a1fb-1a4a5635c0a7
23552890923ANDAPd-Rx Pharmaceuticals, Inc.1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082b3d591ad-4eb7-4cdf-93b2-62cd479e921b
24619190077ANDADirect Rx2014-01-01DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA0850822131a563-f739-4aee-a3ea-cfdc399799ab
25631870196ANDAProficient Rx Lp1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA0842853b7145d7-1ba7-45c1-8202-b8fc575d5a8e
26647250586ANDATya Pharmaceuticals1974-09-30DICYCLOMINE HYDROCHLORIDEORALCAPSULE005270586ANDA084285d64229cc-c087-4fcb-a31b-042cd6bd75d0
27663360911ANDADispensing Solutions, Inc.1986-06-19DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082baae1478-e5e8-44d1-bb8a-9f456861491f
28687889705ANDAPreferred Pharmaceuticals, Inc.2013-02-18DICYCLOMINE HYDROCHLORIDEORALCAPSULE005910794ANDA085082d719366b-8316-4d16-91e3-e1be52337f5b

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040161DICYCLOMINE HYDROCHLORIDETrueHIKMA PHARMACEUTICALS LLC1996-10-01ANDA040161_001Dicyclomine Oral Tablet
2ANDA040204DICYCLOMINE HYDROCHLORIDETrueHIKMA PHARMACEUTICALS LLC1997-02-28ANDA040204_001Dicyclomine Oral Tablet
3ANDA040230DICYCLOMINE HYDROCHLORIDELANNETT CO INC1999-02-26ANDA040230_001Dicyclomine Oral Tablet
4ANDA040317DICYCLOMINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1999-09-07ANDA040317_001Dicyclomine Oral Tablet
5ANDA040319DICYCLOMINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1999-09-07ANDA040319_001Dicyclomine Oral Tablet
6ANDA083179DICYCLOMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1986-02-12ANDA083179_001Dicyclomine Oral Tablet
7ANDA084285DICYCLOMINE HYDROCHLORIDELANNETT CO INCANDA084285_001Dicyclomine Oral Tablet
8ANDA084361DICYCLOMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1986-02-06ANDA084361_001Dicyclomine Oral Tablet
9ANDA084505DICYCLOMINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1986-10-21ANDA084505_001Dicyclomine Oral Tablet
10ANDA084600DICYCLOMINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1985-07-29ANDA084600_001Dicyclomine Oral Tablet
11ANDA085082DICYCLOMINE HYDROCHLORIDEWATSON LABORATORIES INC1986-06-19ANDA085082_001Dicyclomine Oral Tablet
12ANDA085223DICYCLOMINE HYDROCHLORIDEWATSON LABORATORIES INC1986-07-30ANDA085223_001Dicyclomine Oral Tablet
13ANDA088585DICYCLOMINE HYDROCHLORIDETruePIONEER PHARMACEUTICALS INC1986-08-20ANDA088585_001Dicyclomine Oral Tablet
14ANDA089361DICYCLOMINE HYDROCHLORIDETruePIONEER PHARMACEUTICALS INC1989-01-10ANDA089361_001Dicyclomine Oral Tablet
15NDA007409BENTYLFOREST LABORATORIES INC1984-10-15NDA007409_001, NDA007409_003Dicyclomine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040161_001discontinuedDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalse1996-10-01DICYCLOMINE HYDROCHLORIDE
2ANDA040204_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalse1997-02-28DICYCLOMINE HYDROCHLORIDE
3ANDA040230_001RXDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalseAB1999-02-26DICYCLOMINE HYDROCHLORIDE
4ANDA040317_001RXDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalseAB1999-09-07DICYCLOMINE HYDROCHLORIDE
5ANDA040319_001RXDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB1999-09-07DICYCLOMINE HYDROCHLORIDE
6ANDA083179_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalse1986-02-12DICYCLOMINE HYDROCHLORIDE
7ANDA084285_001RXDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalseABDICYCLOMINE HYDROCHLORIDE
8ANDA084361_001discontinuedDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalse1986-02-06DICYCLOMINE HYDROCHLORIDE
9ANDA084505_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalse1986-10-21DICYCLOMINE HYDROCHLORIDE
10ANDA084600_001discontinuedDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalse1985-07-29DICYCLOMINE HYDROCHLORIDE
11ANDA085082_001RXDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB1986-06-19DICYCLOMINE HYDROCHLORIDE
12ANDA085223_001RXDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalseAB1986-07-30DICYCLOMINE HYDROCHLORIDE
13ANDA088585_001discontinuedDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETFalse1986-08-20DICYCLOMINE HYDROCHLORIDE
14ANDA089361_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalse1989-01-10DICYCLOMINE HYDROCHLORIDE
15NDA007409_001RXDICYCLOMINE HYDROCHLORIDE (20MG)ORALTABLETTrueAB1984-10-15BENTYL
16NDA007409_003RXDICYCLOMINE HYDROCHLORIDE (10MG)ORALCAPSULETrueAB1984-10-15BENTYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1150078be-0792-4053-b6d3-641cae923b09 (view SPL)DICYCLOMINE HYDROCHLORIDE TABLETS, USPDICYCLOMINE HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-012604290155, 604290156Dicyclomine Oral Tablet
22131a563-f739-4aee-a3ea-cfdc399799ab (view SPL)DICYCLOMINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-01-272619190077
3399ff144-aeaa-4d9b-a1fb-1a4a5635c0a7 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionCardinal HealthREPACK2014-09-158551545599, 551545684Dicyclomine Oral Tablet
43b7145d7-1ba7-45c1-8202-b8fc575d5a8e (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal useDicyclomine hydrochloride tablets USP, fororal useInitial U.S. Approval: 1950prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870196, 631870410Dicyclomine Oral Tablet
54282ea80-21db-4fd6-9a78-cc06b67b7df3 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2013-07-011521250651
652c8422d-ce70-42bb-9d5b-8b5956239ffd (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-151521250745
754582bac-9386-4070-bfce-8c392172d24d (view SPL)Dicyclomine Hydrochloride Tablets, USPDicyclomine Hydrochloride Capsules, USPRx OnlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-221548680033
859b4c00d-74cd-44a6-a76c-d44e93bbeca9 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionLiberty Pharmaceuticals, Inc.2014-02-101004407384
95a553bda-1e3d-4b80-913f-73dd54655033 (view SPL)These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for dicyclomine hydrochloride.Dicyclomine Hydrochloride Capsules, USP for oral useDicyclomine Hydrochloride Tablets, USP for oral useInitial U.S. Approval: 1950prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2012-10-187001433126, 001431227Dicyclomine Oral Tablet
105cc4daa2-f108-4672-9dd8-06c3785bed28 (view SPL)70010341Dicyclomine HClCapsules USPDicyclomine HClTablets USPRevised: May 2003Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-06-201422540057
115f5d7145-118b-4cab-bfe0-19f7740ef1fe (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900127
12695888d3-135d-49b4-9327-8c9ec83c343f (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP.Dicyclomine hydrochloride capsules USP, fororal useDicyclomine hydrochloride tablets USP, fororal useInitial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-291521250058
1381e1264b-6e5f-4d0e-a714-fae75bd270e4 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP.Dicyclomine hydrochloride capsules USP, fororal useDicyclomine hydrochloride tablets USP, fororal useInitial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-093521250058
14820d2d23-34ce-439a-8130-49d9a93c0283 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINEhydrochloridecapsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900129
1583484c6b-08e3-4002-a5b4-c9877c03f3a8 (view SPL)These highlights do not include all the information needed to useDicyclomine Hydrochloride safely and effectively. See full prescribing information for Dicyclomine Hydrochloride. Dicyclomine Hydrochloride Capsules,for oral use. Dicyclomine Hydrochloride Tablets, for oral use. Initial U.S. Approval: 1950prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-04-309006157754
1687cd2a04-54d6-4022-b365-646692a42f56 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-10-1417430630629
1788942e82-b798-4122-9ea2-0932ef09357f (view SPL)These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for dicyclomine hydrochloride.Dicyclomine Hydrochloride Capsules, USP for oral useDicyclomine Hydrochloride Tablets, USP for oral useInitial U.S. Approval: 1950prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-10-213538081055, 538080899Dicyclomine Oral Tablet
188b242ad1-0438-42ed-931b-8f85ea9bc660 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINEhydrochloridecapsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900128, 500900130Dicyclomine Oral Tablet
198c29140b-e181-4807-870f-28e315c6d4c4 (view SPL)70010341Dicyclomine HClCapsules USPDicyclomine HClTablets USPRevised: May 2003Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-073430630112
209cdf9530-8750-4651-9018-1f2ddc8f9aa4 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP.Dicyclomine hydrochloride capsules USP, fororal useDicyclomine hydrochloride tablets USP, fororal useInitial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2014-08-271521250058
21a5937c7b-cdfc-46e6-a0fa-541b24f91d47 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINEhydrochloridecapsules, for oral use DICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-09-0115005910794, 005910795Dicyclomine Oral Tablet
22ac145b81-5f26-4914-b47f-6c4958e94146 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-03-144003781610, 003781620Dicyclomine Oral Tablet
23afdf69a7-6409-4894-b1a8-2e2f99ff021d (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-281499990291
24b3c9dc85-2c6c-44f0-9c98-02673af934cb (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900126, 500901577Dicyclomine Oral Tablet
25b3d591ad-4eb7-4cdf-93b2-62cd479e921b (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. DICYCLOMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-10-0918552890923
26b8c72fd8-6030-4c0a-80a6-d36cf698a576 (view SPL)Dicyclomine HydrochlorideprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-03-191006150327
27b9546f1f-e672-4cb9-a17e-b236fc50c2a8 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2014-02-201521250745
28baae1478-e5e8-44d1-bb8a-9f456861491f (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine hydrochloridecapsules, for oral use Dicyclomine hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-11-052663360911
29bd2cba10-70ec-4d1f-b46c-53d1de2ee130 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-01-1813005270586, 005271282Dicyclomine Oral Tablet
30bf9f9a6c-d2af-4832-b101-a2499a898413 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-2096493490082
31bfefe3d2-990d-4ef4-8ce9-addc24e29fa9 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-01-183504363367
32c2aac506-3f10-4116-9b65-6341aaaf9893 (view SPL)Dicyclomine HydrochlorideprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-271538080611
33c56598d5-9cd1-4cce-b172-ac338775aec7 (view SPL)These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for BENTYL. Initial U.S. Approval: 1950 BENTYL (Dicyclomine hydrochloride USP)prescriptionHuman PrescriptionAptalis Pharma Inc.2013-06-1811589140012, 589140013, 589140080Dicyclomine Injectable Solution
Dicyclomine Oral Tablet
34c8a3893f-612c-4a03-b3de-6caaff80d52b (view SPL)DICYCLOMINE (dicyclomine hydrochloride) capsuleprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-283636293341
35cd19dd27-d52c-41bf-8836-407c5172beb2 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP.Dicyclomine hydrochloride capsules USP, fororal useDicyclomine hydrochloride tablets USP, fororal useInitial U.S. Approval: 1950prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-141521250391
36d2c074e8-9ee2-4bbf-a0a4-6aeba4ad9d50 (view SPL)These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionMylan Institutional Inc.2015-05-013510790118, 510790119Dicyclomine Oral Tablet
37d59bd885-a123-48fc-811e-01f0d976220a (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine hydrochloridecapsules, for oral use Dicyclomine hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690417
38d64229cc-c087-4fcb-a31b-042cd6bd75d0 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-01-182647250586
39d719366b-8316-4d16-91e3-e1be52337f5b (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloridesafely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine hydrochloridecapsules, for oral use Dicyclomine hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-123687889705
40d9daced1-c2e0-47c3-b590-c77f3da94e88 (view SPL)These highlights do not include all the information needed to usedicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, fororal use Dicyclomine hydrochloride tablets USP, fororal use Initial U.S. Approval: 1950prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-271332610963, 332610163Dicyclomine Oral Tablet
41da10031f-9da8-49a2-a019-5ce80c4b7ede (view SPL)Dicyclomine HydrochlorideprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-06-011216950218
42ddc61a17-0577-47dc-b323-05e2594a09e6 (view SPL)DICYCLOMINE (dicyclomine hydrochloride) capsuleprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900077
43f325dd3d-8ebe-4aa3-8c45-43438c75defe (view SPL)Dicyclomine HCl Capsules USP Dicyclomine HCl Tablets USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-271538080233, 538080234Dicyclomine Oral Tablet
44fcca6fd5-6a67-4bb9-b9f2-634c87b8cc31 (view SPL)These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for dicyclomine hydrochloride.Dicyclomine Hydrochloride Capsules, USP for oral useDicyclomine Hydrochloride Tablets, USP for oral useInitial U.S. Approval: 1950prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-11-192687889935

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII