Disopyramide Oral Capsule

Brand(s)
Norpace
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G.D. Searle Llc Division Of Pfizer Inc (2010-02-24)
Oldest Current Product
1977-09-01
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\DISOPYRAMIDE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\DISOPYRAMIDE PHOSPHATE
ORAL\CAPSULE\DISOPYRAMIDE PHOSPHATE
SPL Active
ORAL\CAPSULE, GELATIN COATED\DISOPYRAMIDE PHOSPHATE
ORAL\CAPSULE\DISOPYRAMIDE PHOSPHATE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\DISOPYRAMIDE
ORAL\CAPSULE\DISOPYRAMIDE

product(s) by strength(s)

disopyramide 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000252752NorpaceNDAG.D. Searle Llc Division Of Pfizer Inc1977-09-01DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATEDNDA017447e2aa1642-d262-4520-bc6a-9fd3ad795677

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933127ANDATeva Pharmaceuticals Usa Inc1990-09-30DISOPYRAMIDE PHOSPHATEORALCAPSULEANDA07010111a68e26-d2e4-48f6-ba0f-9bdd5778f25a
2005915560ANDAWatson Laboratories, Inc.1985-05-31DISOPYRAMIDE PHOSPHATEORALCAPSULEANDA070173aee41c2f-dfe7-4f7b-85bc-04dda0915c27

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910234ANDAAvkare, Inc.2014-01-03DISOPYRAMIDE PHOSPHATEORALCAPSULE000933127ANDA0701019a5bf15c-cb50-78b6-1a2d-8924d904d351
2681510526NorpaceNDACarilion Materials Management1982-07-20DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATED000252732NDA0186554c02f1b8-4493-429c-b9f7-21f364e330f8
3681513858ANDACarilion Materials Management1990-09-30DISOPYRAMIDE PHOSPHATEORALCAPSULE000933127ANDA070101cdf8d8a6-b524-491f-b7c1-0d23c77abbcd

disopyramide 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000252762NorpaceNDAG.D. Searle Llc Division Of Pfizer Inc1977-09-01DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATEDNDA017447e2aa1642-d262-4520-bc6a-9fd3ad795677

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933129ANDATeva Pharmaceuticals Usa Inc1990-09-30DISOPYRAMIDE PHOSPHATEORALCAPSULEANDA07010211a68e26-d2e4-48f6-ba0f-9bdd5778f25a
2005915561ANDAWatson Laboratories, Inc.1985-05-31DISOPYRAMIDE PHOSPHATEORALCAPSULEANDA070174aee41c2f-dfe7-4f7b-85bc-04dda0915c27

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910235ANDAAvkare, Inc.2014-01-03DISOPYRAMIDE PHOSPHATEORALCAPSULE000933129ANDA0701029a5bf15c-cb50-78b6-1a2d-8924d904d351
2681510527NorpaceNDACarilion Materials Management1982-07-20DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATED000252742NDA018655f5e0c230-db38-4476-8357-9a227ccff1bc
3681510528ANDACarilion Materials Management1990-09-30DISOPYRAMIDE PHOSPHATEORALCAPSULE000933129ANDA070102ee7d47d9-1900-4040-92ca-04fe1078defb

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070101DISOPYRAMIDE PHOSPHATETEVA PHARMACEUTICALS USA INC1985-02-22ANDA070101_001
2ANDA070102DISOPYRAMIDE PHOSPHATETEVA PHARMACEUTICALS USA INC1985-02-22ANDA070102_001
3ANDA070138DISOPYRAMIDE PHOSPHATETrueMYLAN PHARMACEUTICALS INC1985-06-14ANDA070138_001
4ANDA070139DISOPYRAMIDE PHOSPHATETrueMYLAN PHARMACEUTICALS INC1985-06-14ANDA070139_001
5ANDA070173DISOPYRAMIDE PHOSPHATEWATSON LABORATORIES INC1985-05-31ANDA070173_001
6ANDA070174DISOPYRAMIDE PHOSPHATEWATSON LABORATORIES INC1985-05-31ANDA070174_001
7ANDA070186DISOPYRAMIDE PHOSPHATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1985-11-18ANDA070186_001
8ANDA070187DISOPYRAMIDE PHOSPHATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1985-11-18ANDA070187_001
9ANDA070240DISOPYRAMIDE PHOSPHATETrueWATSON LABORATORIES INC1986-02-02ANDA070240_001
10ANDA070241DISOPYRAMIDE PHOSPHATETrueWATSON LABORATORIES INC1986-02-02ANDA070241_001
11ANDA070351DISOPYRAMIDE PHOSPHATETrueMUTUAL PHARMACEUTICAL CO INC1985-12-17ANDA070351_001
12ANDA070352DISOPYRAMIDE PHOSPHATETrueMUTUAL PHARMACEUTICAL CO INC1985-12-17ANDA070352_001
13ANDA070470DISOPYRAMIDE PHOSPHATETrueSANDOZ INC1985-12-10ANDA070470_001
14ANDA070471DISOPYRAMIDE PHOSPHATETrueSANDOZ INC1985-12-10ANDA070471_001
15ANDA070940DISOPYRAMIDE PHOSPHATETrueSUPERPHARM CORP1987-02-09ANDA070940_001
16ANDA070941DISOPYRAMIDE PHOSPHATETrueSUPERPHARM CORP1987-02-09ANDA070941_001
17ANDA071190DISOPYRAMIDE PHOSPHATETrueINTERPHARM INC1987-01-15ANDA071190_001
18ANDA071191DISOPYRAMIDE PHOSPHATETrueINTERPHARM INC1987-01-15ANDA071191_001
19ANDA071200DISOPYRAMIDE PHOSPHATETrueNESHER PHARMACEUTICALS USA LLC1987-12-15ANDA071200_001Disopyramide Extended Release Oral Capsule
20NDA017447NORPACEGD SEARLE LLCNDA017447_001, NDA017447_002
21NDA018655NORPACE CRGD SEARLE LLC1982-07-20NDA018655_001, NDA018655_002Disopyramide Extended Release Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070101_001RXDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalseAB1985-02-22DISOPYRAMIDE PHOSPHATE
2ANDA070102_001RXDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalseAB1985-02-22DISOPYRAMIDE PHOSPHATE
3ANDA070138_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1985-06-14DISOPYRAMIDE PHOSPHATE
4ANDA070139_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1985-06-14DISOPYRAMIDE PHOSPHATE
5ANDA070173_001RXDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalseAB1985-05-31DISOPYRAMIDE PHOSPHATE
6ANDA070174_001RXDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalseAB1985-05-31DISOPYRAMIDE PHOSPHATE
7ANDA070186_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1985-11-18DISOPYRAMIDE PHOSPHATE
8ANDA070187_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1985-11-18DISOPYRAMIDE PHOSPHATE
9ANDA070240_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1986-02-02DISOPYRAMIDE PHOSPHATE
10ANDA070241_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1986-02-02DISOPYRAMIDE PHOSPHATE
11ANDA070351_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1985-12-17DISOPYRAMIDE PHOSPHATE
12ANDA070352_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1985-12-17DISOPYRAMIDE PHOSPHATE
13ANDA070470_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1985-12-10DISOPYRAMIDE PHOSPHATE
14ANDA070471_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1985-12-10DISOPYRAMIDE PHOSPHATE
15ANDA070940_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1987-02-09DISOPYRAMIDE PHOSPHATE
16ANDA070941_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1987-02-09DISOPYRAMIDE PHOSPHATE
17ANDA071190_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalse1987-01-15DISOPYRAMIDE PHOSPHATE
18ANDA071191_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULEFalse1987-01-15DISOPYRAMIDE PHOSPHATE
19ANDA071200_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse1987-12-15DISOPYRAMIDE PHOSPHATE
20NDA017447_001RXDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULEFalseABNORPACE
21NDA017447_002RXDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULETrueABNORPACE
22NDA018655_001RXDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse1982-07-20NORPACE CR
23NDA018655_002RXDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULE, EXTENDED RELEASETrueAB1982-07-20NORPACE CR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
111a68e26-d2e4-48f6-ba0f-9bdd5778f25a (view SPL)DISOPYRAMIDE PHOSPHATE CAPSULES, USP31273129 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-309000933127, 000933129
24c02f1b8-4493-429c-b9f7-21f364e330f8 (view SPL)Norpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-02-242681510526
39a5bf15c-cb50-78b6-1a2d-8924d904d351 (view SPL)DISOPYRAMIDE PHOSPHATE CAPSULES, USPprescriptionHuman PrescriptionAvkare, Inc.2014-01-314422910234, 422910235
4aee41c2f-dfe7-4f7b-85bc-04dda0915c27 (view SPL)DisopyramidePhosphateCapsules, USPRevised: March 2015Rx only183994-1prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-03-015005915560, 005915561
5cdf8d8a6-b524-491f-b7c1-0d23c77abbcd (view SPL)DISOPYRAMIDE PHOSPHATE CAPSULES, USP 3127 3129prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-09-262681513858
6e2aa1642-d262-4520-bc6a-9fd3ad795677 (view SPL)Norpace disopyramide phosphate capsules Norpace CRdisopyramide phosphateextended-release capsulesprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncAPI MANUFACTURE, MANUFACTURE2010-02-243000252752, 000252762, 000252732, 000252742Disopyramide Extended Release Oral Capsule
7ee7d47d9-1900-4040-92ca-04fe1078defb (view SPL)DISOPYRAMIDE PHOSPHATE CAPSULES, USP 3127 3129prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-09-262681510528
8f5e0c230-db38-4476-8357-9a227ccff1bc (view SPL)Norpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-02-242681510527

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