Glucagon Injection

Brand(s)
GlucaGen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2014-12-12)
Oldest Current Product
1999-03-01
License(s)
NDA
RxNORM
INJECTION\GLUCAGON
FDAOB
INJECTION\INJECTION\GLUCAGON HYDROCHLORIDE RECOMBINANT\rdfq
INJECTION\INJECTION\GLUCAGON RECOMBINANT\rdfq
INTRAMUSCULAR, INTRAVENOUS\POWDER\GLUCAGON HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\GLUCAGON HYDROCHLORIDE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GLUCAGON HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\GLUCAGON
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GLUCAGON

product(s) by strength(s)

glucagon 1 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001697065GlucaGenNDANovo Nordisk2005-06-22GLUCAGON HYDROCHLORIDEKITNDA020918f09feb8e-6651-4708-a811-bb5264712059
2553900004GlucaGenNDABedford Laboratories2005-06-22GLUCAGON HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA0209188184c282-4b36-4ae8-a51b-2b22aff34a64
3633230596NDAApp Pharmaceuticals, Llc2015-05-08GLUCAGON HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA2018498c8acad6-44cc-43aa-966b-027e053be8f5, e4be1c0e-0fe6-45a0-9229-5cde98434b84

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)dose formequivalent productapplicationspl
1548685070NDAPhysicians Total Care, Inc.2004-05-24GLUCAGONKIT000028031NDA020928d52486b3-623d-4e9c-b551-943e53be2783
2647258031NDATya Pharmaceuticals1999-03-01000028031NDA020928b53a7c5d-2de6-40a3-9015-ca18cf84df19

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020918GLUCAGENNOVO NORDISK PHARMACEUTICALS INC1998-06-22NDA020918_001
2NDA020928GLUCAGONELI LILLY AND CO1998-09-11NDA020928_001
3NDA201849GLUCAGONFRESENIUS KABI USA LLC2015-05-08NDA201849_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020918_001RXGLUCAGON HYDROCHLORIDE RECOMBINANT (EQ 1MG BASE/VIAL)INJECTIONTrue1998-06-22GLUCAGEN
2NDA020928_001RXGLUCAGON RECOMBINANT (1MG/VIAL)INJECTIONTrue1998-09-11GLUCAGON
3NDA201849_001RXGLUCAGON HYDROCHLORIDE (EQ 1MG BASE/VIAL)POWDERTrue2015-05-08GLUCAGON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18184c282-4b36-4ae8-a51b-2b22aff34a64 (view SPL)These highlights do not include all the information needed to use GlucaGen safely and effectively. See full prescribing information for GlucaGen.GlucaGen(glucagon [rDNA origin] for injection)Initial U.S. Approval: 1998prescriptionHuman PrescriptionBedford LaboratoriesMANUFACTURE2014-12-125553900004
28c8acad6-44cc-43aa-966b-027e053be8f5 (view SPL)These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION. GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-161633230596
3b53a7c5d-2de6-40a3-9015-ca18cf84df19 (view SPL)INFORMATION FOR THE PHYSICIAN GLUCAGON FOR INJECTION (rDNA ORIGIN)prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-10-032647258031
4d52486b3-623d-4e9c-b551-943e53be2783 (view SPL)INFORMATION FOR THE PHYSICIANGLUCAGONFOR INJECTION(rDNA ORIGIN)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-181548685070
5e4be1c0e-0fe6-45a0-9229-5cde98434b84 (view SPL)These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION. GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-121633230596
6f09feb8e-6651-4708-a811-bb5264712059 (view SPL)These highlights do not include all the information needed to use GlucaGen safely and effectively. See full prescribing information for GlucaGen.GlucaGen (glucagon [rDNA origin] for injection)Initial U.S. Approval: 1998prescriptionHuman PrescriptionNovo NordiskAPI MANUFACTURE, MANUFACTURE2014-12-128001697065
7f143db10-e889-41c3-84ed-603a0ab02f61 (view SPL)INFORMATION FOR THE PHYSICIANGLUCAGONFOR INJECTION(rDNA ORIGIN)prescriptionHuman PrescriptionEli Lilly And Company2013-10-038000028031
8ff16e4b1-3668-4cb4-91a4-77ee509cd6f6 (view SPL)These highlights do not include all the information needed to use GlucaGen safely and effectively. See full prescribing information for GlucaGen.GlucaGen(glucagon [rDNA origin] for injection)Initial U.S. Approval: 1998prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.MANUFACTURE2014-12-121005970053, 005970260

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