Sotalol Oral Tablet

Brand(s)
Betapace, Sorine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upsher-Smith Laboratories, Inc. (2015-06-24)
Oldest Current Product
1992-10-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\SOTALOL
FDAOB
ORAL\TABLET\SOTALOL HYDROCHLORIDE
SPL Active
ORAL\TABLET\SOTALOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\SOTALOL

product(s) by strength(s)

sotalol hydrochloride 120 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190109BetapaceNDABayer Healthcare Pharmaceuticals Inc.1992-10-30SOTALOL HYDROCHLORIDEORALTABLETNDA019865c4caf469-f684-4f6d-98e8-b6a2fff1de98

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931060ANDATeva Pharmaceuticals Usa Inc2000-05-05SOTALOL HYDROCHLORIDEORALTABLETANDA0754298e2772cb-7dea-42d1-ba31-d479ba7cb09a
2001152722ANDAGlobal Pharmaceuticals2000-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075663f0ee7f5c-3e8b-4104-a95c-5420ebd4092b
3001850170ANDAEon Labs, Inc.2000-05-01SOTALOL HYDROCHLORIDEORALTABLETANDA07536684562767-c0b0-4a59-a2ed-ea3874176af5
4002450013SorineANDAUpsher-Smith Laboratories, Inc.2011-02-15SOTALOL HYDROCHLORIDEORALTABLETANDA0755006ee6e904-a8e2-41d4-8261-67103ecfa605
5003785124ANDAMylan Pharmaceuticals Inc.2007-02-20SOTALOL HYDROCHLORIDEORALTABLETANDA0776166524fdc2-f931-463d-ba77-b6ab1688fe45
6006035770ANDAQualitest Pharmaceuticals2003-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075563576905b7-6e6d-4aa0-b690-24be26e70cd2
7605050159ANDAApotex Corp2003-02-01SOTALOL HYDROCHLORIDEORALTABLETANDA0761404902d850-55eb-b2e0-918c-911d52b2e2c6
8605050223ANDAApotex Corp2003-09-09SOTALOL HYDROCHLORIDEORALTABLETANDA0762141a56c82e-7ecd-43b0-2899-f89e47adf7db

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910761ANDAAvkare, Inc.2014-02-13SOTALOL HYDROCHLORIDEORALTABLET605050223ANDA0762141bd7a8de-4a66-0a8d-e249-e6c03774eddc
2548685614ANDAPhysicians Total Care, Inc.2009-04-08SOTALOL HYDROCHLORIDEORALTABLET001850170ANDA0753661436950d-a07f-43bb-811f-201f2991dbf6
3604290391ANDAGolden State Medical Supply, Inc.2003-09-09SOTALOL HYDROCHLORIDEORALTABLET605050223ANDA076214981c90c0-3afd-4fb4-9440-c383df76d4a2
4604290749ANDAGolden State Medical Supply, Inc.2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050159ANDA0761406674d53a-7137-4822-8841-4982f702a1b8

sotalol hydrochloride 160 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190116BetapaceNDABayer Healthcare Pharmaceuticals Inc.2000-02-22SOTALOL HYDROCHLORIDEORALTABLETNDA02115121aea811-f47d-4a44-a552-dfc46d2773bf

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931062ANDATeva Pharmaceuticals Usa Inc2000-05-05SOTALOL HYDROCHLORIDEORALTABLETANDA0754298e2772cb-7dea-42d1-ba31-d479ba7cb09a
2001152733ANDAGlobal Pharmaceuticals2000-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075663f0ee7f5c-3e8b-4104-a95c-5420ebd4092b
3001850177ANDAEon Labs, Inc.2000-05-01SOTALOL HYDROCHLORIDEORALTABLETANDA07536684562767-c0b0-4a59-a2ed-ea3874176af5
4002450014SorineANDAUpsher-Smith Laboratories, Inc.2011-02-15SOTALOL HYDROCHLORIDEORALTABLETANDA0755006ee6e904-a8e2-41d4-8261-67103ecfa605
5003785125ANDAMylan Pharmaceuticals Inc.2007-02-20SOTALOL HYDROCHLORIDEORALTABLETANDA0776166524fdc2-f931-463d-ba77-b6ab1688fe45
6006035771ANDAQualitest Pharmaceuticals2003-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075563576905b7-6e6d-4aa0-b690-24be26e70cd2
7605050081ANDAApotex Corp2003-02-01SOTALOL HYDROCHLORIDEORALTABLETANDA0761404902d850-55eb-b2e0-918c-911d52b2e2c6
8605050224ANDAApotex Corp2003-09-09SOTALOL HYDROCHLORIDEORALTABLETANDA0762141a56c82e-7ecd-43b0-2899-f89e47adf7db

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560964ANDALake Erie Medical Dba Quality Care Products Llc2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035771ANDA0755637cc5592d-42ca-46b6-99c4-3027bc62f12a
2422910762ANDAAvkare, Inc.2014-02-13SOTALOL HYDROCHLORIDEORALTABLET605050224ANDA0762141bd7a8de-4a66-0a8d-e249-e6c03774eddc
3548685549ANDAPhysicians Total Care, Inc.2006-03-14SOTALOL HYDROCHLORIDEORALTABLET001850177ANDA0753661436950d-a07f-43bb-811f-201f2991dbf6
4604290392ANDAGolden State Medical Supply, Inc.2003-09-09SOTALOL HYDROCHLORIDEORALTABLET605050224ANDA076214981c90c0-3afd-4fb4-9440-c383df76d4a2
5604290750ANDAGolden State Medical Supply, Inc.2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050081ANDA0761406674d53a-7137-4822-8841-4982f702a1b8

sotalol hydrochloride 240 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931063ANDATeva Pharmaceuticals Usa Inc2000-05-05SOTALOL HYDROCHLORIDEORALTABLETANDA0754298e2772cb-7dea-42d1-ba31-d479ba7cb09a
2001152744ANDAGlobal Pharmaceuticals2000-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075663f0ee7f5c-3e8b-4104-a95c-5420ebd4092b
3001850174ANDAEon Labs, Inc.2000-05-01SOTALOL HYDROCHLORIDEORALTABLETANDA07536684562767-c0b0-4a59-a2ed-ea3874176af5
4002450015SorineANDAUpsher-Smith Laboratories, Inc.2011-02-15SOTALOL HYDROCHLORIDEORALTABLETANDA0755006ee6e904-a8e2-41d4-8261-67103ecfa605
5006035772ANDAQualitest Pharmaceuticals2003-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075563576905b7-6e6d-4aa0-b690-24be26e70cd2
6605050082ANDAApotex Corp2003-02-01SOTALOL HYDROCHLORIDEORALTABLETANDA0761404902d850-55eb-b2e0-918c-911d52b2e2c6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290751ANDAGolden State Medical Supply, Inc.2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050082ANDA0761406674d53a-7137-4822-8841-4982f702a1b8

sotalol hydrochloride 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190115BetapaceNDABayer Healthcare Pharmaceuticals Inc.2000-02-22SOTALOL HYDROCHLORIDEORALTABLETNDA02115121aea811-f47d-4a44-a552-dfc46d2773bf

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931061ANDATeva Pharmaceuticals Usa Inc2000-05-04SOTALOL HYDROCHLORIDEORALTABLETANDA0754298e2772cb-7dea-42d1-ba31-d479ba7cb09a
2001152711ANDAGlobal Pharmaceuticals2000-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075663f0ee7f5c-3e8b-4104-a95c-5420ebd4092b
3001850171ANDAEon Labs, Inc.2000-05-01SOTALOL HYDROCHLORIDEORALTABLETANDA07536684562767-c0b0-4a59-a2ed-ea3874176af5
4002450012SorineANDAUpsher-Smith Laboratories, Inc.2011-02-15SOTALOL HYDROCHLORIDEORALTABLETANDA0755006ee6e904-a8e2-41d4-8261-67103ecfa605
5003785123ANDAMylan Pharmaceuticals Inc.2007-02-20SOTALOL HYDROCHLORIDEORALTABLETANDA0776166524fdc2-f931-463d-ba77-b6ab1688fe45
6006035769ANDAQualitest Pharmaceuticals2003-11-07SOTALOL HYDROCHLORIDEORALTABLETANDA075563576905b7-6e6d-4aa0-b690-24be26e70cd2
7605050080ANDAApotex Corp2003-02-01SOTALOL HYDROCHLORIDEORALTABLETANDA0761404902d850-55eb-b2e0-918c-911d52b2e2c6
8605050222ANDAApotex Corp2003-09-09SOTALOL HYDROCHLORIDEORALTABLETANDA0762141a56c82e-7ecd-43b0-2899-f89e47adf7db

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155552ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA0755632d1e7246-eb9f-468a-8f52-0c9feae947b3
2006157888ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050080ANDA0761405be593e4-72a2-497f-a7ec-b309d4a35629
3216950397ANDARebel Distributors Corp2000-05-01SOTALOL HYDROCHLORIDEORALTABLET001850171ANDA0753666383dc39-15a9-4260-8064-18a8c83004b1
4353560935ANDALake Erie Medical Dba Quality Care Products Llc2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA075563a014b73b-95a5-4ad4-a494-278822db95b9
5422910760ANDAAvkare, Inc.2014-02-13SOTALOL HYDROCHLORIDEORALTABLET605050222ANDA0762141bd7a8de-4a66-0a8d-e249-e6c03774eddc
6430630133ANDAPd-Rx Pharmaceuticals, Inc.2000-05-01SOTALOL HYDROCHLORIDEORALTABLET001850171ANDA075366dceafc93-2edb-4be7-bbde-014e7778b087
7532170011ANDAAidarex Pharmaceuticals Llc2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050080ANDA0761406481858a-353e-4b2a-af48-6c5d13ee0b2a
8548684435ANDAPhysicians Total Care, Inc.2000-12-04SOTALOL HYDROCHLORIDEORALTABLET001850171ANDA0753661436950d-a07f-43bb-811f-201f2991dbf6
9551545616SorineANDACardinal Health2011-02-15SOTALOL HYDROCHLORIDEORALTABLET002450012ANDA075500f16f9ae6-d29f-4b31-a240-c7ebb0d7d36a
10604290390ANDAGolden State Medical Supply, Inc.2003-09-09SOTALOL HYDROCHLORIDEORALTABLET605050222ANDA076214981c90c0-3afd-4fb4-9440-c383df76d4a2
11604290748ANDAGolden State Medical Supply, Inc.2003-02-01SOTALOL HYDROCHLORIDEORALTABLET605050080ANDA0761406674d53a-7137-4822-8841-4982f702a1b8
12631870426ANDAProficient Rx Lp2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA07556303de4b65-29b0-4e30-a94b-b5877a050f93
13636294719ANDABryant Ranch Prepack2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA07556386e6e910-5910-4e0a-828c-7eddda12fd94
14636294720ANDABryant Ranch Prepack2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA0755633433ddec-0a48-45fc-9850-c9a53147333c
15680840497ANDAAmerican Health Packaging2013-06-12SOTALOL HYDROCHLORIDEORALTABLET001850171ANDA075366a04796d9-0e24-4abd-9f6b-8b9b756b8fd7
16680840654ANDAAmerican Health Packaging2014-03-18SOTALOL HYDROCHLORIDEORALTABLET605050080ANDA0761404614480b-b36e-4dbd-9fc0-d083890d297d
17681512702ANDACarilion Materials Management2003-11-07SOTALOL HYDROCHLORIDEORALTABLET006035769ANDA075563d288de0a-913d-4617-aa47-c6201ebf2a0d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075237SOTALOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2000-05-01ANDA075237_001, ANDA075237_002, ANDA075237_003, ANDA075237_004
2ANDA075238SOTALOL HYDROCHLORIDETrueWATSON LABORATORIES INC2000-07-13ANDA075238_001, ANDA075238_002, ANDA075238_003, ANDA075238_004
3ANDA075366SOTALOL HYDROCHLORIDESANDOZ INC2000-05-01ANDA075366_001, ANDA075366_002, ANDA075366_003, ANDA075366_004
4ANDA075429SOTALOL HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2000-05-01ANDA075429_001, ANDA075429_002, ANDA075429_003, ANDA075429_004
5ANDA075500SORINEUPSHER SMITH LABORATORIES INC2001-04-27ANDA075500_001, ANDA075500_002, ANDA075500_003, ANDA075500_004
6ANDA075515SOTALOL HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC2001-10-15ANDA075515_001, ANDA075515_002, ANDA075515_003, ANDA075515_004
7ANDA075563SOTALOL HYDROCHLORIDEVINTAGE PHARMACEUTICALS INC2003-11-07ANDA075563_001, ANDA075563_002, ANDA075563_003, ANDA075563_004
8ANDA075663SOTALOL HYDROCHLORIDEIMPAX PHARMACEUTICALS2000-11-07ANDA075663_001, ANDA075663_002, ANDA075663_003, ANDA075663_004
9ANDA075725SOTALOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2000-12-19ANDA075725_001, ANDA075725_002, ANDA075725_003, ANDA075725_004
10ANDA076140SOTALOL HYDROCHLORIDEAPOTEX INC ETOBICOKE SITE2002-09-26ANDA076140_001, ANDA076140_002, ANDA076140_003, ANDA076140_004
11ANDA076214SOTALOL HYDROCHLORIDEAPOTEX INC2003-08-27ANDA076214_001, ANDA076214_002, ANDA076214_003
12ANDA076576SOTALOL HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC2004-04-08ANDA076576_001, ANDA076576_002, ANDA076576_003
13ANDA076883SOTALOL HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2004-07-26ANDA076883_001, ANDA076883_002, ANDA076883_003
14ANDA077070SOTALOL HYDROCHLORIDEEPIC PHARMA INC2005-11-04ANDA077070_001, ANDA077070_002, ANDA077070_003
15ANDA077616SOTALOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2007-02-07ANDA077616_001, ANDA077616_002, ANDA077616_003
16NDA019865BETAPACECOVIS PHARMA SARL1992-10-30NDA019865_001, NDA019865_002, NDA019865_003, NDA019865_004, NDA019865_005
17NDA021151BETAPACE AFCOVIS PHARMA SARL2000-02-22NDA021151_001, NDA021151_002, NDA021151_003, NDA021151_005, NDA021151_006, NDA021151_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075237_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
2ANDA075237_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
3ANDA075237_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
4ANDA075237_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
5ANDA075238_001discontinuedSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalse2000-07-13SOTALOL HYDROCHLORIDE
6ANDA075238_002discontinuedSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalse2000-07-13SOTALOL HYDROCHLORIDE
7ANDA075238_003discontinuedSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalse2000-07-13SOTALOL HYDROCHLORIDE
8ANDA075238_004discontinuedSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalse2000-07-13SOTALOL HYDROCHLORIDE
9ANDA075366_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
10ANDA075366_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
11ANDA075366_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
12ANDA075366_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
13ANDA075429_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
14ANDA075429_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
15ANDA075429_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
16ANDA075429_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12000-05-01SOTALOL HYDROCHLORIDE
17ANDA075500_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12001-04-27SORINE
18ANDA075500_002RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12001-04-27SORINE
19ANDA075500_003RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12001-04-27SORINE
20ANDA075500_004RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12001-04-27SORINE
21ANDA075515_001discontinuedSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalse2001-10-15SOTALOL HYDROCHLORIDE
22ANDA075515_002discontinuedSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalse2001-10-15SOTALOL HYDROCHLORIDE
23ANDA075515_003discontinuedSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalse2001-10-15SOTALOL HYDROCHLORIDE
24ANDA075515_004discontinuedSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalse2001-10-15SOTALOL HYDROCHLORIDE
25ANDA075563_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12003-11-07SOTALOL HYDROCHLORIDE
26ANDA075563_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12003-11-07SOTALOL HYDROCHLORIDE
27ANDA075563_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12003-11-07SOTALOL HYDROCHLORIDE
28ANDA075563_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12003-11-07SOTALOL HYDROCHLORIDE
29ANDA075663_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12000-11-07SOTALOL HYDROCHLORIDE
30ANDA075663_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12000-11-07SOTALOL HYDROCHLORIDE
31ANDA075663_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12000-11-07SOTALOL HYDROCHLORIDE
32ANDA075663_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12000-11-07SOTALOL HYDROCHLORIDE
33ANDA075725_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12000-12-19SOTALOL HYDROCHLORIDE
34ANDA075725_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12000-12-19SOTALOL HYDROCHLORIDE
35ANDA075725_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12000-12-19SOTALOL HYDROCHLORIDE
36ANDA075725_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12000-12-19SOTALOL HYDROCHLORIDE
37ANDA076140_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB12002-09-26SOTALOL HYDROCHLORIDE
38ANDA076140_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB12002-09-26SOTALOL HYDROCHLORIDE
39ANDA076140_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB12002-09-26SOTALOL HYDROCHLORIDE
40ANDA076140_004RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB12002-09-26SOTALOL HYDROCHLORIDE
41ANDA076214_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB22003-08-27SOTALOL HYDROCHLORIDE
42ANDA076214_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB22003-08-27SOTALOL HYDROCHLORIDE
43ANDA076214_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB22003-08-27SOTALOL HYDROCHLORIDE
44ANDA076576_001discontinuedSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalse2004-04-08SOTALOL HYDROCHLORIDE
45ANDA076576_002discontinuedSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalse2004-04-08SOTALOL HYDROCHLORIDE
46ANDA076576_003discontinuedSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalse2004-04-08SOTALOL HYDROCHLORIDE
47ANDA076883_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB22004-07-26SOTALOL HYDROCHLORIDE
48ANDA076883_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB22004-07-26SOTALOL HYDROCHLORIDE
49ANDA076883_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB22004-07-26SOTALOL HYDROCHLORIDE
50ANDA077070_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB22005-11-04SOTALOL HYDROCHLORIDE
51ANDA077070_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB22005-11-04SOTALOL HYDROCHLORIDE
52ANDA077070_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB22005-11-04SOTALOL HYDROCHLORIDE
53ANDA077616_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB22007-02-07SOTALOL HYDROCHLORIDE
54ANDA077616_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB22007-02-07SOTALOL HYDROCHLORIDE
55ANDA077616_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETFalseAB22007-02-07SOTALOL HYDROCHLORIDE
56NDA019865_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB11992-10-30BETAPACE
57NDA019865_002RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETTrueAB11992-10-30BETAPACE
58NDA019865_003RXSOTALOL HYDROCHLORIDE (240MG)ORALTABLETFalseAB11992-10-30BETAPACE
59NDA019865_004discontinuedSOTALOL HYDROCHLORIDE (320MG)ORALTABLETFalse1992-10-30BETAPACE
60NDA019865_005RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB11994-04-20BETAPACE
61NDA021151_001RXSOTALOL HYDROCHLORIDE (80MG)ORALTABLETFalseAB22000-02-22BETAPACE AF
62NDA021151_002RXSOTALOL HYDROCHLORIDE (120MG)ORALTABLETFalseAB22000-02-22BETAPACE AF
63NDA021151_003RXSOTALOL HYDROCHLORIDE (160MG)ORALTABLETTrueAB22000-02-22BETAPACE AF
64NDA021151_005discontinuedSOTALOL HYDROCHLORIDE (100MG)ORALTABLETFalse2003-03-14BETAPACE AF
65NDA021151_006discontinuedSOTALOL HYDROCHLORIDE (40MG)ORALTABLETFalse2003-04-02BETAPACE AF
66NDA021151_007discontinuedSOTALOL HYDROCHLORIDE (60MG)ORALTABLETFalse2003-04-02BETAPACE AF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103de4b65-29b0-4e30-a94b-b5877a050f93 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870426
21436950d-a07f-43bb-811f-201f2991dbf6 (view SPL)Sotalol Hydrochloride Tablets USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-231548684435, 548685549, 548685614
31a56c82e-7ecd-43b0-2899-f89e47adf7db (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP(AF)80 mg, 120 mg and 160 mg Rx OnlyprescriptionHuman PrescriptionApotex Corp2015-09-228605050222, 605050223, 605050224
41bd7a8de-4a66-0a8d-e249-e6c03774eddc (view SPL)SOTALOL HYDROCHLORIDE TABLETS(AF)80 mg, 120 mg and 160 mgprescriptionHuman PrescriptionAvkare, Inc.2014-02-131422910760, 422910761, 422910762
521aea811-f47d-4a44-a552-dfc46d2773bf (view SPL)BETAPACE AF ( sotalol HCI)prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2012-06-285504190115, 504190116, 504190119
62d1e7246-eb9f-468a-8f52-0c9feae947b3 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-11-142006155552
73433ddec-0a48-45fc-9850-c9a53147333c (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281001636294720
84614480b-b36e-4dbd-9fc0-d083890d297d (view SPL)Sotalol Hydrochloride Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-03-181680840654
94902d850-55eb-b2e0-918c-911d52b2e2c6 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP 80 mg, 120 mg, 160 mg and 240 mg Rx OnlyprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-04-232605050080, 605050081, 605050082, 605050159
10576905b7-6e6d-4aa0-b690-24be26e70cd2 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-08-287006035769, 006035770, 006035771, 006035772
115be593e4-72a2-497f-a7ec-b309d4a35629 (view SPL)Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2015-09-301006157888
126383dc39-15a9-4260-8064-18a8c83004b1 (view SPL)Sotalol Hydrochloride Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950397
136481858a-353e-4b2a-af48-6c5d13ee0b2a (view SPL)Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mgprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-10-031532170011
146524fdc2-f931-463d-ba77-b6ab1688fe45 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2011-12-154003785123, 003785124, 003785125
156674d53a-7137-4822-8841-4982f702a1b8 (view SPL)Sotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290748, 604290749, 604290750, 604290751
166ee6e904-a8e2-41d4-8261-67103ecfa605 (view SPL)SORINE (Sotalol Hydrochloride Tablets, USP)prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-06-245002450012, 002450013, 002450014, 002450015
177cc5592d-42ca-46b6-99c4-3027bc62f12a (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-231353560964
1884562767-c0b0-4a59-a2ed-ea3874176af5 (view SPL)Sotalol Hydrochloride Tablets USPprescriptionHuman PrescriptionEon Labs, Inc.2013-12-0518001850170, 001850171, 001850174, 001850177
1986e6e910-5910-4e0a-828c-7eddda12fd94 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-141000636294719
208e2772cb-7dea-42d1-ba31-d479ba7cb09a (view SPL)SOTALOL HYDROCHLORIDE TABLETS USP 1061106010621063prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-10-179000931060, 000931061, 000931062, 000931063
21981c90c0-3afd-4fb4-9440-c383df76d4a2 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 mg, 120 mg and 160 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-01-032604290390, 604290391, 604290392
22a014b73b-95a5-4ad4-a494-278822db95b9 (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-08-151353560935
23a04796d9-0e24-4abd-9f6b-8b9b756b8fd7 (view SPL)Sotalol Hydrochloride Tablets USP 8249701/0113prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-06-122680840497
24c4caf469-f684-4f6d-98e8-b6a2fff1de98 (view SPL)Betapace ( sotalol HCl )prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2012-07-026504190109, 504190105, 504190106
25d288de0a-913d-4617-aa47-c6201ebf2a0d (view SPL)SOTALOL HYDROCHLORIDE TABLETS, USP Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-10-062681512702
26dceafc93-2edb-4be7-bbde-014e7778b087 (view SPL)Sotalol Hydrochloride Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-0111430630133
27f0ee7f5c-3e8b-4104-a95c-5420ebd4092b (view SPL)Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg, and 240 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2010-09-101001152711, 001152722, 001152733, 001152744
28f16f9ae6-d29f-4b31-a240-c7ebb0d7d36a (view SPL)SORINE (Sotalol HCl) TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-263551545616

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