Midodrine Oral Tablet

Brand(s)
Proamatine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2012-04-01)
Oldest Current Product
1996-09-06
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\MIDODRINE
FDAOB
ORAL\TABLET\MIDODRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\MIDODRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\MIDODRINE

product(s) by strength(s)

midodrine hydrochloride 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001154233ANDAGlobal Pharmaceuticals2005-12-16MIDODRINE HYDROCHLORIDEORALTABLETANDA076449e2e3db6b-054a-4f63-9936-482663c6395a
2001850149ANDAEon Labs, Inc.2002-07-02MIDODRINE HYDROCHLORIDEORALTABLETANDA076514937e679e-1e86-48de-a69f-83ed7a98e76e
3002450213ANDAUpsher-Smith Laboratories, Inc.2004-11-03MIDODRINE HYDROCHLORIDEORALTABLETANDA0767254c3517f3-1c68-4ade-b5f1-c488a3a335c1
4003781903ANDAMylan Pharmaceuticals Inc.2003-09-11MIDODRINE HYDROCHLORIDEORALTABLETANDA07657732fad00b-7e7b-4d35-9e8b-fdc979fdb88e
5422910617ANDAAvkare, Inc.2005-12-272015-01-06MIDODRINE HYDROCHLORIDEORALTABLETANDA07644925517a4a-f81d-1a64-6bcc-502bff04a165
6605051325ANDAApotex Corp2006-09-12MIDODRINE HYDROCHLORIDEORALTABLETANDA077746aec0d2de-ce83-b7c2-5d10-740607d50521

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157559ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-09-10MIDODRINE HYDROCHLORIDEORALTABLET003781903ANDA07657776d71394-cbef-48e1-b99e-9a80bd5babfc
2216950181ANDARebel Distributors Corp2002-07-02MIDODRINE HYDROCHLORIDEORALTABLET001850149ANDA0765144a81751e-1c63-4b0d-8f63-bf7c4d155f22
3502680566ANDAAvpak2011-08-17MIDODRINE HYDROCHLORIDEORALTABLET001154233ANDA076449a00026cf-d946-b267-e735-c6a38cd5c2fa
4680840886ANDAAmerican Health Packaging2015-09-01MIDODRINE HYDROCHLORIDEORALTABLET001154233ANDA07644929031ab1-c24a-440e-9a1d-6bac90380680

midodrine hydrochloride 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001154211ANDAGlobal Pharmaceuticals2004-05-27MIDODRINE HYDROCHLORIDEORALTABLETANDA076449e2e3db6b-054a-4f63-9936-482663c6395a
2001850040ANDAEon Labs, Inc.2003-09-11MIDODRINE HYDROCHLORIDEORALTABLETANDA076514937e679e-1e86-48de-a69f-83ed7a98e76e
3002450211ANDAUpsher-Smith Laboratories, Inc.2004-11-03MIDODRINE HYDROCHLORIDEORALTABLETANDA0767254c3517f3-1c68-4ade-b5f1-c488a3a335c1
4003781901ANDAMylan Pharmaceuticals Inc.2003-09-11MIDODRINE HYDROCHLORIDEORALTABLETANDA07657732fad00b-7e7b-4d35-9e8b-fdc979fdb88e
5422910615ANDAAvkare, Inc.2004-05-272015-01-06MIDODRINE HYDROCHLORIDEORALTABLETANDA07644925517a4a-f81d-1a64-6bcc-502bff04a165
6605051320ANDAApotex Corp2006-09-12MIDODRINE HYDROCHLORIDEORALTABLETANDA077746aec0d2de-ce83-b7c2-5d10-740607d50521

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1540920003ProamatineNDAShire1996-09-06MIDODRINE HYDROCHLORIDEORALTABLETNDA019815171543e7-a592-4676-88ef-d68f14701d13

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157566ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-09-10MIDODRINE HYDROCHLORIDEORALTABLET003781901ANDA07657776d71394-cbef-48e1-b99e-9a80bd5babfc
2502680564ANDAAvpak2011-08-17MIDODRINE HYDROCHLORIDEORALTABLET001154211ANDA076449a00026cf-d946-b267-e735-c6a38cd5c2fa
3548685930ANDAPhysicians Total Care, Inc.2008-08-19MIDODRINE HYDROCHLORIDEORALTABLET003781901ANDA0765776d83a423-815d-436e-a299-d2d8f7bec49e
4551544989ANDACardinal Health2010-05-11MIDODRINE HYDROCHLORIDEORALTABLET680840240ANDA0765149d1a93ce-f7bc-4fda-877f-826c76e85a28
5680840240ANDAAmerican Health Packaging2010-05-11MIDODRINE HYDROCHLORIDEORALTABLET001850040ANDA076514964e3631-bcd2-49dd-8dbf-9e1de42cebc4
6691890211ANDAAvera Mckennan Hospital2015-03-01MIDODRINE HYDROCHLORIDEORALTABLET002450211ANDA076725ea2fc25e-f27e-44ad-adb9-a42fff6f10c0

midodrine hydrochloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001154222ANDAGlobal Pharmaceuticals2004-05-27MIDODRINE HYDROCHLORIDEORALTABLETANDA076449e2e3db6b-054a-4f63-9936-482663c6395a
2001850043ANDAEon Labs, Inc.2003-09-11MIDODRINE HYDROCHLORIDEORALTABLETANDA076514937e679e-1e86-48de-a69f-83ed7a98e76e
3002450212ANDAUpsher-Smith Laboratories, Inc.2004-11-03MIDODRINE HYDROCHLORIDEORALTABLETANDA0767254c3517f3-1c68-4ade-b5f1-c488a3a335c1
4003781902ANDAMylan Pharmaceuticals Inc.2003-09-11MIDODRINE HYDROCHLORIDEORALTABLETANDA07657732fad00b-7e7b-4d35-9e8b-fdc979fdb88e
5605051321ANDAApotex Corp2006-09-12MIDODRINE HYDROCHLORIDEORALTABLETANDA077746aec0d2de-ce83-b7c2-5d10-740607d50521

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685442ProamatineNDAPhysicians Total Care, Inc.2005-09-30MIDODRINE HYDROCHLORIDEORALTABLET540920004NDA0198159e8874f0-ad2e-41ce-8a35-bed819615a5d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155647ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-09-10MIDODRINE HYDROCHLORIDEORALTABLET003781902ANDA07657776d71394-cbef-48e1-b99e-9a80bd5babfc
2422910616ANDAAvkare, Inc.2004-05-27MIDODRINE HYDROCHLORIDEORALTABLET001154222ANDA07644925517a4a-f81d-1a64-6bcc-502bff04a165
3502680565ANDAAvpak2011-08-17MIDODRINE HYDROCHLORIDEORALTABLET001154222ANDA076449a00026cf-d946-b267-e735-c6a38cd5c2fa
4510790453ANDAMylan Institutional Inc.2006-09-11MIDODRINE HYDROCHLORIDEORALTABLET003781902ANDA076577fd28d383-add9-42a9-ad07-4d7e89f12460
5548685435ANDAPhysicians Total Care, Inc.2006-01-01MIDODRINE HYDROCHLORIDEORALTABLET003781902ANDA0765776d83a423-815d-436e-a299-d2d8f7bec49e
6551545623ANDACardinal Health2004-11-03MIDODRINE HYDROCHLORIDEORALTABLET002450212ANDA07672524847065-0be0-46eb-a084-7e5425a8be73
7551545632ANDACardinal Health2004-11-03MIDODRINE HYDROCHLORIDEORALTABLET002450212ANDA076725b2c3b1f9-effe-4fe8-898a-463f82949095
8551545696ANDACardinal Health2011-01-14MIDODRINE HYDROCHLORIDEORALTABLET510790453ANDA07657766bccee4-b466-4fe9-89d6-8c9eaaa92413
9637390556ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2012-11-26MIDODRINE HYDROCHLORIDEORALTABLET001850043ANDA0765142b24f75c-539b-4a96-802e-f3cc3b55dae2
10680840241ANDAAmerican Health Packaging2010-05-11MIDODRINE HYDROCHLORIDEORALTABLET001850043ANDA076514964e3631-bcd2-49dd-8dbf-9e1de42cebc4
11681512958ANDACarilion Materials Management2004-05-27MIDODRINE HYDROCHLORIDEORALTABLET001154222ANDA0764499d5c58cc-1713-47ff-acbd-5b1fc79f9944

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076449MIDODRINE HYDROCHLORIDEIMPAX PHARMACEUTICALS2004-05-27ANDA076449_001, ANDA076449_002, ANDA076449_003
2ANDA076514MIDODRINE HYDROCHLORIDESANDOZ INC2003-09-11ANDA076514_001, ANDA076514_002, ANDA076514_003
3ANDA076577MIDODRINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2003-09-10ANDA076577_001, ANDA076577_002, ANDA076577_003
4ANDA076725ORVATENUPSHER SMITH LABORATORIES INC2004-11-03ANDA076725_001, ANDA076725_002, ANDA076725_003
5ANDA077746MIDODRINE HYDROCHLORIDEAPOTEX INC ETOBICOKE SITE2006-09-12ANDA077746_001, ANDA077746_002, ANDA077746_003
6NDA019815PROAMATINETrueSHIRE DEVELOPMENT LLC1996-09-06NDA019815_001, NDA019815_002, NDA019815_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076449_001RXMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB2004-05-27MIDODRINE HYDROCHLORIDE
2ANDA076449_002RXMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2004-05-27MIDODRINE HYDROCHLORIDE
3ANDA076449_003RXMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2005-12-16MIDODRINE HYDROCHLORIDE
4ANDA076514_001RXMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB2003-09-11MIDODRINE HYDROCHLORIDE
5ANDA076514_002RXMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2003-09-11MIDODRINE HYDROCHLORIDE
6ANDA076514_003RXMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2004-07-02MIDODRINE HYDROCHLORIDE
7ANDA076577_001RXMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB2003-09-10MIDODRINE HYDROCHLORIDE
8ANDA076577_002RXMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETTrueAB2003-09-10MIDODRINE HYDROCHLORIDE
9ANDA076577_003RXMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2003-09-10MIDODRINE HYDROCHLORIDE
10ANDA076725_001RXMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB2004-11-03ORVATEN
11ANDA076725_002RXMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2004-11-03ORVATEN
12ANDA076725_003RXMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2004-11-03ORVATEN
13ANDA077746_001RXMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB2006-09-12MIDODRINE HYDROCHLORIDE
14ANDA077746_002RXMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2006-09-12MIDODRINE HYDROCHLORIDE
15ANDA077746_003RXMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2006-09-12MIDODRINE HYDROCHLORIDE
16NDA019815_001discontinuedMIDODRINE HYDROCHLORIDE (2.5MG)ORALTABLETFalse1996-09-06PROAMATINE
17NDA019815_002discontinuedMIDODRINE HYDROCHLORIDE (5MG)ORALTABLETFalse1996-09-06PROAMATINE
18NDA019815_003discontinuedMIDODRINE HYDROCHLORIDE (10MG)ORALTABLETFalse2002-03-20PROAMATINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1171543e7-a592-4676-88ef-d68f14701d13 (view SPL)ProAmatine (midodrine hydrochloride)TabletsprescriptionHuman PrescriptionShireMANUFACTURE2009-10-082540920003
224847065-0be0-46eb-a084-7e5425a8be73 (view SPL)Midodrine HCl Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-103551545623
325517a4a-f81d-1a64-6bcc-502bff04a165 (view SPL)MIDODRINE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionAvkare, Inc.2015-01-066422910615, 422910616, 422910617
429031ab1-c24a-440e-9a1d-6bac90380680 (view SPL)MIDODRINE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-131680840886
52b24f75c-539b-4a96-802e-f3cc3b55dae2 (view SPL)Midodrine Hydrochloride TabletsprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2012-11-261637390556
632fad00b-7e7b-4d35-9e8b-fdc979fdb88e (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-04-015003781901, 003781902, 003781903
74a81751e-1c63-4b0d-8f63-bf7c4d155f22 (view SPL)Midodrine Hydrochloride Tablets 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-291216950181
84c3517f3-1c68-4ade-b5f1-c488a3a335c1 (view SPL)Midodrine HCl Tablets, USPprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-11-025002450211, 002450212, 002450213
966bccee4-b466-4fe9-89d6-8c9eaaa92413 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-144551545696
106d83a423-815d-436e-a299-d2d8f7bec49e (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-022548685435, 548685930
1176d71394-cbef-48e1-b99e-9a80bd5babfc (view SPL)MIDODRINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-03-0810006155647, 006157559, 006157566
12937e679e-1e86-48de-a69f-83ed7a98e76e (view SPL)Midodrine Hydrochloride Tablets USPprescriptionHuman PrescriptionEon Labs, Inc.2014-06-2518001850040, 001850043, 001850149
13964e3631-bcd2-49dd-8dbf-9e1de42cebc4 (view SPL)Midodrine Hydrochloride TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-164680840240, 680840241
149d1a93ce-f7bc-4fda-877f-826c76e85a28 (view SPL)Midodrine Hydrochloride TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-303551544989
159d5c58cc-1713-47ff-acbd-5b1fc79f9944 (view SPL)MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-11-142681512958
169e8874f0-ad2e-41ce-8a35-bed819615a5d (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-261548685442
17a00026cf-d946-b267-e735-c6a38cd5c2fa (view SPL)MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionAvpak2014-10-159502680564, 502680565, 502680566
18aec0d2de-ce83-b7c2-5d10-740607d50521 (view SPL)Midodrine Hydrochloride Tablets, USP 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-04-201605051320, 605051321, 605051325
19b2c3b1f9-effe-4fe8-898a-463f82949095 (view SPL)Midodrine HCl Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-021551545632
20e2e3db6b-054a-4f63-9936-482663c6395a (view SPL)MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2013-11-144001154211, 001154222, 001154233
21ea2fc25e-f27e-44ad-adb9-a42fff6f10c0 (view SPL)Midodrine HCl Tablets, USPprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-061691890211
22fd28d383-add9-42a9-ad07-4d7e89f12460 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-10-052510790453

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