Acarbose Oral Tablet

Brand(s)
Precose
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-03-11)
Oldest Current Product
2007-11-19
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ACARBOSE
FDAOB
ORAL\TABLET\ACARBOSE
SPL Active
ORAL\TABLET\ACARBOSE
SPL Moiety
ORAL\TABLET\ACARBOSE

product(s) by strength(s)

acarbose 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190862PrecoseNDABayer Healthcare Pharmaceuticals Inc.2008-01-30ACARBOSEORALTABLETNDA02048229a6f213-bc93-4dbd-bab0-744722b6f0b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540142ANDARoxane Laboratories, Inc2008-05-07ACARBOSEORALTABLETANDA078470352dd336-d3f9-4ac5-a000-91d3aef7aca3
2001151152ANDAGlobal Pharmaceuticals2009-05-14ACARBOSEORALTABLETANDA078441c41eaba7-49d5-43a4-9e4e-1ebc4da28982
3003782822ANDAMylan Pharmaceuticals Inc.2011-01-06ACARBOSEORALTABLETANDA091053b56f1c19-b798-46d2-9ad1-73816ed86ef3
4162520525ANDAActavis Pharma, Inc.2008-05-07ACARBOSEORALTABLETANDA0775326c2db888-775c-4baf-a1b4-1cfa63b83357
5231550149ANDAHeritage Pharmaceuticals Inc.2012-07-30ACARBOSEORALTABLETANDA20227129939129-7d09-4c22-bf3e-491a8a97f4c4
6477810342NDA AUTHORIZED GENERICAlvogen, Inc.2008-01-30ACARBOSEORALTABLETNDA020482e4148493-e3bd-4530-8fb6-cdb5197c010e
7695430122ANDAVirtus Pharmaceuticals2015-02-01ACARBOSEORALTABLETANDA0913436cd185e6-3205-484c-be49-456acfc7eb11
8764390122ANDAVirtus Pharmaceuticals2013-10-09ACARBOSEORALTABLETANDA091343f87e7022-0129-4a01-9bd6-1205ae9c05cb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910132ANDAAvkare, Inc.2013-12-24ACARBOSEORALTABLET695430122ANDA091343858c8cdd-ccf1-79c9-c245-7a852d280f20

acarbose 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190863PrecoseNDABayer Healthcare Pharmaceuticals Inc.2008-01-30ACARBOSEORALTABLETNDA02048229a6f213-bc93-4dbd-bab0-744722b6f0b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540140ANDARoxane Laboratories, Inc2008-05-07ACARBOSEORALTABLETANDA078470352dd336-d3f9-4ac5-a000-91d3aef7aca3
2001151150ANDAGlobal Pharmaceuticals2009-05-14ACARBOSEORALTABLETANDA078441c41eaba7-49d5-43a4-9e4e-1ebc4da28982
3003782820ANDAMylan Pharmaceuticals Inc.2011-01-06ACARBOSEORALTABLETANDA091053b56f1c19-b798-46d2-9ad1-73816ed86ef3
4162520523ANDAActavis Pharma, Inc.2008-05-07ACARBOSEORALTABLETANDA0775326c2db888-775c-4baf-a1b4-1cfa63b83357
5231550147ANDAHeritage Pharmaceuticals Inc.2012-07-30ACARBOSEORALTABLETANDA20227129939129-7d09-4c22-bf3e-491a8a97f4c4
6477810340NDA AUTHORIZED GENERICAlvogen, Inc.2008-01-30ACARBOSEORALTABLETNDA020482e4148493-e3bd-4530-8fb6-cdb5197c010e
7518620210ANDALibertas Pharma, Inc.2011-07-27ACARBOSEORALTABLETANDA090912dbb04848-93e2-42ca-a709-6a396913507e
8643800758ANDAStrides Arcolab Limited2011-07-28ACARBOSEORALTABLETANDA090912656769ee-e292-4950-83df-a38e6b1a9d6e
9695430120ANDAVirtus Pharmaceuticals2015-02-01ACARBOSEORALTABLETANDA0913436cd185e6-3205-484c-be49-456acfc7eb11
10764390120ANDAVirtus Pharmaceuticals2013-10-09ACARBOSEORALTABLETANDA091343f87e7022-0129-4a01-9bd6-1205ae9c05cb

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910130ANDAAvkare, Inc.2013-12-24ACARBOSEORALTABLET695430120ANDA091343858c8cdd-ccf1-79c9-c245-7a852d280f20
2548685831PrecoseNDAPhysicians Total Care, Inc.2007-11-19ACARBOSEORALTABLET504190863NDA020482e2158832-ad0b-4b9c-bbf0-1608a177bf85
3548685945ANDAPhysicians Total Care, Inc.2008-10-03ACARBOSEORALTABLET000540140ANDA07847026bca6c9-074d-480d-bd57-1e8fa9b3d05e

acarbose 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190861PrecoseNDABayer Healthcare Pharmaceuticals Inc.2008-01-30ACARBOSEORALTABLETNDA02048229a6f213-bc93-4dbd-bab0-744722b6f0b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540141ANDARoxane Laboratories, Inc2008-05-07ACARBOSEORALTABLETANDA078470352dd336-d3f9-4ac5-a000-91d3aef7aca3
2001151151ANDAGlobal Pharmaceuticals2009-05-14ACARBOSEORALTABLETANDA078441c41eaba7-49d5-43a4-9e4e-1ebc4da28982
3003782821ANDAMylan Pharmaceuticals Inc.2011-01-06ACARBOSEORALTABLETANDA091053b56f1c19-b798-46d2-9ad1-73816ed86ef3
4162520524ANDAActavis Pharma, Inc.2008-05-07ACARBOSEORALTABLETANDA0775326c2db888-775c-4baf-a1b4-1cfa63b83357
5231550148ANDAHeritage Pharmaceuticals Inc.2012-07-30ACARBOSEORALTABLETANDA20227129939129-7d09-4c22-bf3e-491a8a97f4c4
6477810341NDA AUTHORIZED GENERICAlvogen, Inc.2008-01-30ACARBOSEORALTABLETNDA020482e4148493-e3bd-4530-8fb6-cdb5197c010e
7695430121ANDAVirtus Pharmaceuticals2015-02-01ACARBOSEORALTABLETANDA0913436cd185e6-3205-484c-be49-456acfc7eb11
8764390121ANDAVirtus Pharmaceuticals2013-10-09ACARBOSEORALTABLETANDA091343f87e7022-0129-4a01-9bd6-1205ae9c05cb

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910131ANDAAvkare, Inc.2013-12-24ACARBOSEORALTABLET695430121ANDA091343858c8cdd-ccf1-79c9-c245-7a852d280f20
2433530908PrecoseNDAAphena Pharma Solutions - Tennessee, Llc2008-01-30ACARBOSEORALTABLET504190861NDA020482c85bc02a-bf18-4690-84b8-2c256bce5f9f
3552890171ANDAPd-Rx Pharmaceuticals, Inc.2008-05-07ACARBOSEORALTABLET000540141ANDA078470bc76f641-efca-42b9-96ea-728b86ef54ec

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077532ACARBOSEWATSON LABORATORIES INC2008-05-07ANDA077532_001, ANDA077532_002, ANDA077532_003
2ANDA078441ACARBOSEIMPAX LABORATORIES INC2009-05-14ANDA078441_001, ANDA078441_002, ANDA078441_003
3ANDA078470ACARBOSEROXANE LABORATORIES INC2008-05-07ANDA078470_001, ANDA078470_002, ANDA078470_003
4ANDA090912ACARBOSESTRIDES PHARMA GLOBAL PTE LTD2011-07-27ANDA090912_001, ANDA090912_002, ANDA090912_003
5ANDA091053ACARBOSEMYLAN PHARMACEUTICALS INC2011-01-06ANDA091053_001, ANDA091053_002, ANDA091053_003
6ANDA091343ACARBOSEVIRTUS PHARMACEUTICAL INC2013-10-17ANDA091343_001, ANDA091343_002, ANDA091343_003
7ANDA202271ACARBOSEEMCURE PHARMACEUTICALS LTD2012-02-07ANDA202271_001, ANDA202271_002, ANDA202271_003
8NDA020482PRECOSEBAYER HEALTHCARE PHARMACEUTICALS INC1995-09-06NDA020482_001, NDA020482_002, NDA020482_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077532_001RXACARBOSE (25MG)ORALTABLETFalseAB2008-05-07ACARBOSE
2ANDA077532_002RXACARBOSE (50MG)ORALTABLETFalseAB2008-05-07ACARBOSE
3ANDA077532_003RXACARBOSE (100MG)ORALTABLETFalseAB2008-05-07ACARBOSE
4ANDA078441_001RXACARBOSE (25MG)ORALTABLETFalseAB2009-05-14ACARBOSE
5ANDA078441_002RXACARBOSE (50MG)ORALTABLETFalseAB2009-05-14ACARBOSE
6ANDA078441_003RXACARBOSE (100MG)ORALTABLETFalseAB2009-05-14ACARBOSE
7ANDA078470_001RXACARBOSE (25MG)ORALTABLETFalseAB2008-05-07ACARBOSE
8ANDA078470_002RXACARBOSE (50MG)ORALTABLETFalseAB2008-05-07ACARBOSE
9ANDA078470_003RXACARBOSE (100MG)ORALTABLETFalseAB2008-05-07ACARBOSE
10ANDA090912_001RXACARBOSE (25MG)ORALTABLETFalseAB2011-07-27ACARBOSE
11ANDA090912_002RXACARBOSE (50MG)ORALTABLETFalseAB2011-07-27ACARBOSE
12ANDA090912_003RXACARBOSE (100MG)ORALTABLETFalseAB2011-07-27ACARBOSE
13ANDA091053_001RXACARBOSE (25MG)ORALTABLETFalseAB2011-01-06ACARBOSE
14ANDA091053_002RXACARBOSE (50MG)ORALTABLETFalseAB2011-01-06ACARBOSE
15ANDA091053_003RXACARBOSE (100MG)ORALTABLETFalseAB2011-01-06ACARBOSE
16ANDA091343_001RXACARBOSE (25MG)ORALTABLETFalseAB2013-10-17ACARBOSE
17ANDA091343_002RXACARBOSE (50MG)ORALTABLETFalseAB2013-10-17ACARBOSE
18ANDA091343_003RXACARBOSE (100MG)ORALTABLETFalseAB2013-10-17ACARBOSE
19ANDA202271_001RXACARBOSE (25MG)ORALTABLETFalseAB2012-02-07ACARBOSE
20ANDA202271_002RXACARBOSE (50MG)ORALTABLETFalseAB2012-02-07ACARBOSE
21ANDA202271_003RXACARBOSE (100MG)ORALTABLETFalseAB2012-02-07ACARBOSE
22NDA020482_001RXACARBOSE (50MG)ORALTABLETFalseAB1995-09-06PRECOSE
23NDA020482_002RXACARBOSE (100MG)ORALTABLETFalseAB1995-09-06PRECOSE
24NDA020482_004RXACARBOSE (25MG)ORALTABLETTrueAB1997-05-29PRECOSE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
126bca6c9-074d-480d-bd57-1e8fa9b3d05e (view SPL)Acarbose TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-121548685945
229939129-7d09-4c22-bf3e-491a8a97f4c4 (view SPL)prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2013-10-2312231550147, 231550148, 231550149
329a6f213-bc93-4dbd-bab0-744722b6f0b8 (view SPL)PRECOSE (acarbose tablets)prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-03-114504190861, 504190862, 504190863
4352dd336-d3f9-4ac5-a000-91d3aef7aca3 (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2015-04-276000540140, 000540141, 000540142
5656769ee-e292-4950-83df-a38e6b1a9d6e (view SPL)Acarbose TabletsprescriptionHuman PrescriptionStrides Arcolab LimitedAnalysis, Manufacture, Pack2013-11-072643800758
66c2db888-775c-4baf-a1b4-1cfa63b83357 (view SPL)ACARBOSE TABLETSprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE, PACK2014-09-018162520523, 162520524, 162520525
76cd185e6-3205-484c-be49-456acfc7eb11 (view SPL)Acarbose Tablets25 mg, 50 mg and 100 mgRx OnlyprescriptionHuman PrescriptionVirtus Pharmaceuticals2015-07-012695430120, 695430121, 695430122
8858c8cdd-ccf1-79c9-c245-7a852d280f20 (view SPL)Acarbose Tablets25 mg, 50 mg and 100 mgRx OnlyprescriptionHuman PrescriptionAvkare, Inc.2015-10-153422910130, 422910131, 422910132
9b56f1c19-b798-46d2-9ad1-73816ed86ef3 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-295003782820, 003782821, 003782822
10bc76f641-efca-42b9-96ea-728b86ef54ec (view SPL)Acarbose TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-04-183552890171
11c41eaba7-49d5-43a4-9e4e-1ebc4da28982 (view SPL)ACARBOSE TABLETS 25 mg, 50 mg, and 100 mgprescriptionHuman PrescriptionGlobal Pharmaceuticals2015-01-074001151150, 001151151, 001151152
12c85bc02a-bf18-4690-84b8-2c256bce5f9f (view SPL)PRECOSE ( acarbose tablets)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-291433530908
13dbb04848-93e2-42ca-a709-6a396913507e (view SPL)Acarbose TabletsprescriptionHuman PrescriptionLibertas Pharma, Inc.2013-01-051518620210
14e2158832-ad0b-4b9c-bbf0-1608a177bf85 (view SPL)PRECOSE ( acarbose tablets)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-231548685831
15e4148493-e3bd-4530-8fb6-cdb5197c010e (view SPL)AcarboseprescriptionHuman PrescriptionAlvogen, Inc.MANUFACTURE2015-03-113477810340, 477810341, 477810342
16f87e7022-0129-4a01-9bd6-1205ae9c05cb (view SPL)Acarbose Tablets25 mg, 50 mg and 100 mgRx OnlyprescriptionHuman PrescriptionVirtus Pharmaceuticals2013-09-252764390120, 764390121, 764390122

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