Procainamide Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-08-04)
Oldest Current Product
1986-02-12
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PROCAINAMIDE
FDAOB
INJECTION\INJECTION\PROCAINAMIDE HYDROCHLORIDE\rdfq
ORAL\CAPSULE\PROCAINAMIDE HYDROCHLORIDE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PROCAINAMIDE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PROCAINAMIDE

product(s) by strength(s)

procainamide hydrochloride 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091902ANDAHospira, Inc.1986-02-12, 2014-07-01PROCAINAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA08906917e47845-daad-434c-a784-6d3875b0d704, c954f46b-38cc-4be7-9386-479aa83e8afa

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551546986ANDACardinal Health2011-07-08PROCAINAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091902ANDA089069dfd657ec-aaf5-4f9e-85d0-0a2a081ceaf7
2637390459ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-02-01PROCAINAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091902ANDA0890694e23837d-d376-4c8e-a94e-1ddb585dbbf7

procainamide hydrochloride 500 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091903ANDAHospira, Inc.1986-02-12, 2014-07-01PROCAINAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA08907017e47845-daad-434c-a784-6d3875b0d704, c954f46b-38cc-4be7-9386-479aa83e8afa

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544740ANDACardinal Health1986-02-12PROCAINAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091903ANDA089070dfd657ec-aaf5-4f9e-85d0-0a2a081ceaf7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087079PROCAINAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA087079_001
2ANDA087080PROCAINAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA087080_001
3ANDA088530PROCAINAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1985-03-04ANDA088530_001
4ANDA088531PROCAINAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1985-03-04ANDA088531_001
5ANDA088532PROCAINAMIDE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INC1985-03-04ANDA088532_001
6ANDA088636PROCAINAMIDE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEM1984-07-31ANDA088636_001
7ANDA088637PROCAINAMIDE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEM1984-07-31ANDA088637_001
8ANDA088824PROCAINAMIDE HYDROCHLORIDETruePHARMAFAIR INC1985-11-20ANDA088824_001
9ANDA088830PROCAINAMIDE HYDROCHLORIDETruePHARMAFAIR INC1985-11-20ANDA088830_001
10ANDA089029PROCAINAMIDE HYDROCHLORIDETrueHIKMA MAPLE LTD1986-04-17ANDA089029_001
11ANDA089030PROCAINAMIDE HYDROCHLORIDETrueHIKMA MAPLE LTD1986-04-17ANDA089030_001
12ANDA089069PROCAINAMIDE HYDROCHLORIDEHOSPIRA INC1986-02-12ANDA089069_001
13ANDA089070PROCAINAMIDE HYDROCHLORIDEHOSPIRA INC1986-02-12ANDA089070_001
14ANDA089415PROCAINAMIDE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA089415_001
15ANDA089416PROCAINAMIDE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA089416_001
16ANDA089528PROCAINAMIDE HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1988-05-03ANDA089528_001
17ANDA089529PROCAINAMIDE HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1988-05-03ANDA089529_001
18ANDA089537PROCAINAMIDE HYDROCHLORIDETrueHOSPIRA INC1987-08-25ANDA089537_001
19NDA007335PRONESTYLTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBNDA007335_001, NDA007335_002, NDA007335_003, NDA007335_004, NDA007335_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA087079_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePROCAINAMIDE HYDROCHLORIDE
2ANDA087080_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalsePROCAINAMIDE HYDROCHLORIDE
3ANDA088530_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1985-03-04PROCAINAMIDE HYDROCHLORIDE
4ANDA088531_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1985-03-04PROCAINAMIDE HYDROCHLORIDE
5ANDA088532_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1985-03-04PROCAINAMIDE HYDROCHLORIDE
6ANDA088636_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1984-07-31PROCAINAMIDE HYDROCHLORIDE
7ANDA088637_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1984-07-31PROCAINAMIDE HYDROCHLORIDE
8ANDA088824_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1985-11-20PROCAINAMIDE HYDROCHLORIDE
9ANDA088830_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1985-11-20PROCAINAMIDE HYDROCHLORIDE
10ANDA089029_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1986-04-17PROCAINAMIDE HYDROCHLORIDE
11ANDA089030_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1986-04-17PROCAINAMIDE HYDROCHLORIDE
12ANDA089069_001RXPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONTrue1986-02-12PROCAINAMIDE HYDROCHLORIDE
13ANDA089070_001RXPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONTrue1986-02-12PROCAINAMIDE HYDROCHLORIDE
14ANDA089415_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1986-11-17PROCAINAMIDE HYDROCHLORIDE
15ANDA089416_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1986-11-17PROCAINAMIDE HYDROCHLORIDE
16ANDA089528_001discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1988-05-03PROCAINAMIDE HYDROCHLORIDE
17ANDA089529_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1988-05-03PROCAINAMIDE HYDROCHLORIDE
18ANDA089537_001discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalse1987-08-25PROCAINAMIDE HYDROCHLORIDE
19NDA007335_001discontinuedPROCAINAMIDE HYDROCHLORIDE (250MG)ORALCAPSULEFalsePRONESTYL
20NDA007335_002discontinuedPROCAINAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePRONESTYL
21NDA007335_003discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG)ORALCAPSULEFalsePRONESTYL
22NDA007335_004discontinuedPROCAINAMIDE HYDROCHLORIDE (375MG)ORALCAPSULEFalsePRONESTYL
23NDA007335_005discontinuedPROCAINAMIDE HYDROCHLORIDE (500MG/ML)INJECTIONFalsePRONESTYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117e47845-daad-434c-a784-6d3875b0d704 (view SPL)PROCAINAMIDE HYDROCHLORIDEprescriptionHuman PrescriptionHospira, Inc.2014-04-2112004091902, 004091903
24e23837d-d376-4c8e-a94e-1ddb585dbbf7 (view SPL)PROCAINAMIDE HYDROCHLORIDEInjection, USPMultiple-dose Fliptop VialprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-01-141637390459
3c954f46b-38cc-4be7-9386-479aa83e8afa (view SPL)Procainamide Hydrochloride Injection USPprescriptionHuman PrescriptionHospira, Inc.analysis, api manufacture, manufacture2014-08-041004091902, 004091903
4dfd657ec-aaf5-4f9e-85d0-0a2a081ceaf7 (view SPL)PROCAINAMIDE HYDROCHLORIDEprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-292551544740, 551546986

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