Neostigmine Injectable Solution

Brand(s)
Bloxiverz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Clat Pharmaceuticals, Llc (2015-10-23)
Oldest Current Product
1973-01-01
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\NEOSTIGMINE
FDAOB
INTRAVENOUS\SOLUTION\NEOSTIGMINE METHYLSULFATE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NEOSTIGMINE METHYLSULFATE
INTRAMUSCULAR\INJECTION\NEOSTIGMINE METHYLSULFATE
INTRAVENOUS\INJECTION, SOLUTION\NEOSTIGMINE METHYLSULFATE
INTRAVENOUS\INJECTION\NEOSTIGMINE METHYLSULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NEOSTIGMINE
INTRAMUSCULAR\INJECTION\NEOSTIGMINE
INTRAVENOUS\INJECTION, SOLUTION\NEOSTIGMINE
INTRAVENOUS\INJECTION\NEOSTIGMINE

product(s) by strength(s)

neostigmine methylsulfate 0.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416141UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1973-01-01NEOSTIGMINE METHYLSULFATEINTRAMUSCULARINJECTIONa5d3d266-0e81-4663-a973-b0aee049e06b
2633230413NDAApp Pharmaceuticals, Llc2015-01-08NEOSTIGMINE METHYLSULFATEINTRAVENOUSINJECTION, SOLUTIONNDA2036296448229c-e650-47ba-bb00-cba3604502c5, d0e11e4c-41c3-4874-b567-579db655fba3
3760140002BloxiverzNDAClat Pharmaceuticals, Llc2013-07-24NEOSTIGMINE METHYLSULFATEINTRAVENOUSINJECTIONNDA20407879ee2111-d65c-11e1-9b23-0800200c9a66

neostigmine methylsulfate 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416077UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1973-01-01NEOSTIGMINE METHYLSULFATEINTRAMUSCULARINJECTION6c3a7e99-cbde-43a8-acb9-6b414820cd46
2525330046UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-02-03NEOSTIGMINE METHYLSULFATEINTRAVENOUSINJECTION, SOLUTION86963fc9-468c-4842-a76a-c5c1f5510c75
3633230383UNAPPROVED DRUG OTHER MARKETING CATEGORYApp Pharmaceuticals, Llc2000-09-01NEOSTIGMINE METHYLSULFATEINTRAMUSCULARINJECTION, SOLUTIONda49e6de-5ff9-4682-bdb8-c06827219a56
4760140003BloxiverzNDAClat Pharmaceuticals, Llc2013-07-24NEOSTIGMINE METHYLSULFATEINTRAVENOUSINJECTIONNDA20407879ee2111-d65c-11e1-9b23-0800200c9a66

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1617860452NDARemedyrepack Inc.2015-10-26NEOSTIGMINE METHYLSULFATEINTRAVENOUSINJECTION, SOLUTION633230415NDA203629a3c356d7-90de-499a-9aa3-a857df89a315

application(s)

#idtitleapplicantapprovedapproved drug
1NDA203629NEOSTIGMINE METHYLSULFATEFRESENIUS KABI USA LLC2015-01-08NDA203629_001, NDA203629_002
2NDA204078BLOXIVERZECLAT PHARMACEUTICALS LLC2013-05-31NDA204078_001, NDA204078_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203629_001RXNEOSTIGMINE METHYLSULFATE (5MG/10ML)INTRAVENOUSSOLUTIONFalse2015-01-08NEOSTIGMINE METHYLSULFATE
2NDA203629_002RXNEOSTIGMINE METHYLSULFATE (10MG/10ML)INTRAVENOUSSOLUTIONFalse2015-01-08NEOSTIGMINE METHYLSULFATE
3NDA204078_001RXNEOSTIGMINE METHYLSULFATE (5MG/10ML)INTRAVENOUSSOLUTIONTrue2013-05-31BLOXIVERZ
4NDA204078_002RXNEOSTIGMINE METHYLSULFATE (10MG/10ML)INTRAVENOUSSOLUTIONTrue2013-05-31BLOXIVERZ

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16448229c-e650-47ba-bb00-cba3604502c5 (view SPL)These highlights do not include all the information needed to use NEOSTIGMINE METHYLSULFATE injection safely and effectively. See full prescribing information for NEOSTIGMINE METHYLSULFATE injection. NEOSTIGMINE METHYLSULFATE injection, for intravenous useInitial U.S. Approval: 1939prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-01-191633230413, 633230415
26c3a7e99-cbde-43a8-acb9-6b414820cd46 (view SPL)Neostigmine Methylsulfate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-09-271006416077, 006416076
379ee2111-d65c-11e1-9b23-0800200c9a66 (view SPL)These highlights do not include all the information needed to use BLOXIVERZ safely and effectively. See full prescribing information for BLOXIVERZ. BLOXIVERZ (Neostigmine Methylsulfate Injection),for intravenous use Initial U.S. Approval: 1939prescriptionHuman PrescriptionClat Pharmaceuticals, Llc2015-10-2310760140002, 760140003
486963fc9-468c-4842-a76a-c5c1f5510c75 (view SPL)Neostigmine Methylsulfate 1:1,000 Injection Solution 5 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-02-031525330046
59dde8277-e2e8-4733-b18d-60124cde070e (view SPL)NEOSTIGMINEMETHYLSULFATEINJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.LABEL, MANUFACTURE, PACK, STERILIZE2011-01-171005170033, 005170034
6a3c356d7-90de-499a-9aa3-a857df89a315 (view SPL)These highlights do not include all the information needed to use NEOSTIGMINE METHYLSULFATE injection safely and effectively. See full prescribing information for NEOSTIGMINE METHYLSULFATE injection.NEOSTIGMINE METHYLSULFATE injection, for intravenous useInitial U.S. Approval: 1939prescriptionHuman PrescriptionRemedyrepack Inc.2015-10-261617860452
7a5d3d266-0e81-4663-a973-b0aee049e06b (view SPL)Neostigmine Methylsulfate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2012-08-271006416141, 006416140
8d0e11e4c-41c3-4874-b567-579db655fba3 (view SPL)These highlights do not include all the information needed to use NEOSTIGMINE METHYLSULFATE injection safely and effectively. See full prescribing information for NEOSTIGMINE METHYLSULFATE injection. NEOSTIGMINE METHYLSULFATE injection, for intravenous useInitial U.S. Approval: 1939prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-08-201633230413, 633230415
9da49e6de-5ff9-4682-bdb8-c06827219a56 (view SPL)Neostigmine Methylsulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-09-132633230383, 633230382

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