Dicyclomine Oral Tablet

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 TABLET\DICYCLOMINE
FDAOB
ORAL\CAPSULE\DICYCLOMINE HYDROCHLORIDE
ORAL\TABLET\DICYCLOMINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\DICYCLOMINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\DICYCLOMINE

product(s) by strength(s)

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080644ANDAState Of Florida Doh Central Pharmacy2009-07-01DICYCLOMINE HYDROCHLORIDEORALTABLET003781610ANDA040319b65264c5-2d4a-4290-a084-ddd533e9e954

dicyclomine hydrochloride 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1589140013BentylNDAAptalis Pharma Inc.1950-05-11DICYCLOMINE HYDROCHLORIDEORALTABLETNDA007409c56598d5-9cd1-4cce-b172-ac338775aec7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781620ANDAMylan Pharmaceuticals Inc.2009-11-20, 2013-03-27DICYCLOMINE HYDROCHLORIDEORALTABLETANDA040317ac145b81-5f26-4914-b47f-6c4958e94146, ddf980b2-0a5b-4848-b67b-8f54d1dc5ab7
2005271282ANDALannett Company, Inc.1999-02-26DICYCLOMINE HYDROCHLORIDEORALTABLETANDA040230bd2cba10-70ec-4d1f-b46c-53d1de2ee130
3005910795ANDAWatson Laboratories, Inc.1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLETANDA085223a5937c7b-cdfc-46e6-a0fa-541b24f91d47

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431227ANDAWest-Ward Pharmaceutical Corp1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLETANDA0401615a553bda-1e3d-4b80-913f-73dd54655033
2004401385ANDALiberty Pharmaceuticals, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA0401613aaeff2a-834e-4f27-ab97-9c5a87c0891b
3006151516ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161a3fa1a75-cf2b-452e-9e4c-25ef37b711be
4009040195ANDAMajor1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLETANDA040161823052b8-1ee4-4628-aa97-b862406b0d75
5105440597ANDABlenheim Pharmacal, Inc.2011-04-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161d70e3238-cb91-44eb-8598-f8713b89be97
6165900324ANDAStat Rx Usa Llc1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA04016159b1b2cc-73ce-49cf-a87a-05a2d6428be5
7242360231ANDARemedyrepack Inc.2013-03-15DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161ca27aae8-20fb-4096-a3d8-83658f4b0b51
8493490002ANDARemedyrepack Inc.2010-07-23DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161a9e59aae-8575-4659-97a5-c4289296f62d
9529590221ANDAH.J. Harkins Company, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161aa8350bd-f832-4983-baed-2a6978819b49
10538080899ANDAState Of Florida Doh Central Pharmacy2014-01-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA04016188942e82-b798-4122-9ea2-0932ef09357f
11545690419ANDAA-S Medication Solutions Llc1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA04016104df2eb1-c8dc-4b83-abb2-deaaa8acd33b
12548680818ANDAPhysicians Total Care, Inc.1995-01-23DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA0401618b7af7c1-72ce-4d29-947f-aa6dd24f078b
13552890095ANDAPd-Rx Pharmaceuticals, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161f4b07de4-cc96-4615-b1cc-8338920bdeee
14604290156ANDAGolden State Medical Supply, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161150078be-0792-4053-b6d3-641cae923b09
15636291299ANDABryant Ranch Prepack1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA040161c12cc75f-08e6-426a-aa8b-7757e53fc687
16687889934ANDAPreferred Pharmaceuticals, Inc.1996-10-01DICYCLOMINE HYDROCHLORIDEORALTABLET001431227ANDA0401617454bfef-ee61-4226-839e-47bba65f9125

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157755ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA08522347e1a332-823e-45cc-9f30-dfae8a1886dd
2105440560ANDABlenheim Pharmacal, Inc.2013-11-13DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA0402300fecc9b6-076b-148b-e054-00144ff88e88
3216950219ANDARebel Distributors Corp1999-02-26DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA04023057ab6992-7b98-4503-b4bb-98d76ccf603e
4242360385ANDARemedyrepack Inc.2013-02-13DICYCLOMINE HYDROCHLORIDEORALTABLET003781620ANDA04031728092bf4-c1f2-4aad-a87e-3666c6e79063
5332610163ANDAAidarex Pharmaceuticals Llc1999-02-26DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA040230d9daced1-c2e0-47c3-b590-c77f3da94e88
6430630045ANDAPd-Rx Pharmaceuticals, Inc.1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223da0e1f63-cb90-4c2a-908f-7d81e672be10
7499990081ANDALake Erie Medical Dba Quality Care Products Llc2011-11-18DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223ad7e6eaa-42b8-45fd-aca4-e4b64a9ef20f
8500900130ANDAA-S Medication Solutions Llc1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA0852238b242ad1-0438-42ed-931b-8f85ea9bc660
9500901577ANDAA-S Medication Solutions Llc1999-02-26DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA040230b3c9dc85-2c6c-44f0-9c98-02673af934cb
10510790119ANDAMylan Institutional Inc.1998-03-06DICYCLOMINE HYDROCHLORIDEORALTABLET003781620ANDA040317d2c074e8-9ee2-4bbf-a0a4-6aeba4ad9d50
11521250517ANDARemedyrepack Inc.2013-06-24, 2014-02-06DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA0852232be274dd-826c-4446-8872-48de0b65d3ab, 828ac121-4bd6-4a7c-8654-77e4e235bada
12521250666ANDARemedyrepack Inc.2013-07-09, 2013-07-16DICYCLOMINE HYDROCHLORIDEORALTABLET003781620ANDA0403178e1c0219-d4b0-419b-bcd3-3141899d3a48, c74b6c12-9771-4a10-a180-29d25dcfd312
13521250987ANDARemedyrepack Inc.2015-01-02DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA0852231f07cb6f-932e-49d3-8799-6b99cae7fc48
14538080234ANDAState Of Florida Doh Central Pharmacy2009-07-01DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223f325dd3d-8ebe-4aa3-8c45-43438c75defe
15551545684ANDACardinal Health2011-08-16DICYCLOMINE HYDROCHLORIDEORALTABLET510790119ANDA040317399ff144-aeaa-4d9b-a1fb-1a4a5635c0a7
16581180795ANDAClinical Solutions Wholesale1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223722618c7-c65c-47ec-8f1c-16863820ee61
17607600795ANDASt Marys Medical Park Pharmacy1986-07-30DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223da466149-a3d3-4053-a077-a5e5d4e89b5b
18617860159ANDARemedyrepack Inc.2015-01-24DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA040230e4a92e17-0473-4941-aa7c-2906f39682f7
19619190324ANDADirect Rx2014-01-01DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223ebaf5799-80f9-4e16-9e11-99eaf30531f4
20631870410ANDAProficient Rx Lp1999-02-26DICYCLOMINE HYDROCHLORIDEORALTABLET005271282ANDA0402303b7145d7-1ba7-45c1-8202-b8fc575d5a8e
21687889291ANDAPreferred Pharmaceuticals, Inc.2015-05-13DICYCLOMINE HYDROCHLORIDEORALTABLET003781620ANDA040317cfc33579-95e6-49f5-bce9-e185f9ca994a
22687889525ANDAPreferred Pharmaceuticals, Inc.2014-02-21DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223f3a3e5ad-9178-4855-b537-abd125836a07
23759210795ANDALife Line Home Care Services, Inc.2012-02-07DICYCLOMINE HYDROCHLORIDEORALTABLET005910795ANDA085223e576f409-d319-4878-9863-25988be7fde1

application(s)

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

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
104df2eb1-c8dc-4b83-abb2-deaaa8acd33b (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 PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690419
20fecc9b6-076b-148b-e054-00144ff88e88 (view SPL)These highlights do not include all the information needed to use dicyclomine 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, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-251105440560
3150078be-0792-4053-b6d3-641cae923b09 (view SPL)DICYCLOMINE HYDROCHLORIDE TABLETS, USPDICYCLOMINE HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-012604290156, 604290155Dicyclomine Oral Capsule
41f07cb6f-932e-49d3-8799-6b99cae7fc48 (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 PrescriptionRemedyrepack Inc.2015-01-021521250987
528092bf4-c1f2-4aad-a87e-3666c6e79063 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-132242360385
62be274dd-826c-4446-8872-48de0b65d3ab (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 PrescriptionRemedyrepack Inc.2013-06-241521250517
7399ff144-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 HealthREPACK2014-09-158551545684, 551545599Dicyclomine Oral Capsule
83aaeff2a-834e-4f27-ab97-9c5a87c0891b (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 PrescriptionLiberty Pharmaceuticals, Inc.2013-09-061004401385
93b7145d7-1ba7-45c1-8202-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, REPACK2015-02-011631870410, 631870196Dicyclomine Oral Capsule
1047e1a332-823e-45cc-9f30-dfae8a1886dd (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 PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-03-082006157755
1157ab6992-7b98-4503-b4bb-98d76ccf603e (view SPL)Dicyclomine HydrochlorideprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-242216950219
1259b1b2cc-73ce-49cf-a87a-05a2d6428be5 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2009-10-271165900324
135a553bda-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 CorpMANUFACTURE2012-10-187001431227, 001433126Dicyclomine Oral Capsule
14722618c7-c65c-47ec-8f1c-16863820ee61 (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 useDICYCLOMINE hydrochloride tablets, for oral use Initial U.S. Approval: 1950prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-09-011581180795
157454bfef-ee61-4226-839e-47bba65f9125 (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.RELABEL2013-11-182687889934
16823052b8-1ee4-4628-aa97-b862406b0d75 (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 PrescriptionMajor2012-08-162009040195
17828ac121-4bd6-4a7c-8654-77e4e235bada (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 PrescriptionRemedyrepack Inc.2014-02-061521250517
1888942e82-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 Pharmacyrepack2014-10-213538080899, 538081055Dicyclomine Oral Capsule
198b242ad1-0438-42ed-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 Llcrepack2015-02-151500900130, 500900128Dicyclomine Oral Capsule
208b7af7c1-72ce-4d29-947f-aa6dd24f078b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-09-274548680818
218e1c0219-d4b0-419b-bcd3-3141899d3a48 (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.2013-07-161521250666
22a3fa1a75-cf2b-452e-9e4c-25ef37b711be (view SPL)DICYCLOMINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-07-022006151516
23a5937c7b-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, PACK2013-09-0115005910795, 005910794Dicyclomine Oral Capsule
24a9e59aae-8575-4659-97a5-c4289296f62d (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-07-2311493490002
25aa8350bd-f832-4983-baed-2a6978819b49 (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 PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-02-021529590221
26ac145b81-5f26-4914-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.2013-03-144003781620, 003781610Dicyclomine Oral Capsule
27ad7e6eaa-42b8-45fd-aca4-e4b64a9ef20f (view SPL)70010341Dicyclomine HClCapsules USPDicyclomine HClTablets USPRevised: May 2003Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-07-313221499990081
28b3c9dc85-2c6c-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 Llcrepack2015-02-151500901577, 500900126Dicyclomine Oral Capsule
29b65264c5-2d4a-4290-a084-ddd533e9e954 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-08-042538080644
30bd2cba10-70ec-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, PACK2013-01-1813005271282, 005270586Dicyclomine Oral Capsule
31c12cc75f-08e6-426a-aa8b-7757e53fc687 (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 PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-181001636291299
32c56598d5-9cd1-4cce-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.2013-06-1811589140013, 589140012, 589140080Dicyclomine Injectable Solution
Dicyclomine Oral Capsule
33c74b6c12-9771-4a10-a180-29d25dcfd312 (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.2013-07-091521250666
34ca27aae8-20fb-4096-a3d8-83658f4b0b51 (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 PrescriptionRemedyrepack Inc.2013-03-151242360231
35cfc33579-95e6-49f5-bce9-e185f9ca994a (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-05-131687889291
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.2015-05-013510790119, 510790118Dicyclomine Oral Capsule
37d70e3238-cb91-44eb-8598-f8713b89be97 (view SPL)DICYCLOMINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2011-06-071105440597
38d9daced1-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 Llc2013-12-271332610163, 332610963Dicyclomine Oral Capsule
39da0e1f63-cb90-4c2a-908f-7d81e672be10 (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 PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-01-0115430630045
40da466149-a3d3-4053-a077-a5e5d4e89b5b (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 PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2014-12-111607600795
41ddf980b2-0a5b-4848-b67b-8f54d1dc5ab7 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2007-08-032003781620
42e4a92e17-0473-4941-aa7c-2906f39682f7 (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.2015-01-241617860159
43e576f409-d319-4878-9863-25988be7fde1 (view SPL)70010341Dicyclomine HClCapsules USPDicyclomine HClTablets USPRevised: May 2003Rx onlyprescriptionHuman PrescriptionLife Line Home Care Services, Inc.relabel, repack2012-02-071759210795
44ebaf5799-80f9-4e16-9e11-99eaf30531f4 (view SPL)DICYCLOMINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-12-181619190324
45f325dd3d-8ebe-4aa3-8c45-43438c75defe (view SPL)Dicyclomine HCl Capsules USP Dicyclomine HCl Tablets USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-271538080234, 538080233Dicyclomine Oral Capsule
46f3a3e5ad-9178-4855-b537-abd125836a07 (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.REPACK2014-11-122687889525
47f4b07de4-cc96-4615-b1cc-8338920bdeee (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 PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-057552890095

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