Regular Insulin, Human Injectable Solution

Brand(s)
Humulin R, Novolin R
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Eli Lilly And Company (2014-09-23)
Oldest Current Product
1991-06-25
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\REGULAR INSULIN, HUMAN
FDAOB
INJECTION\INJECTION\INSULIN RECOMBINANT HUMAN\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN HUMAN
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN HUMAN

product(s) by strength(s)

regular insulin, human 100 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001691833Novolin RNDANovo Nordisk1991-06-25INSULIN HUMANSUBCUTANEOUSINJECTION, SOLUTIONNDA019938aee7f1f3-612c-4027-8ce9-4fd1f41eed71

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683619Humulin RNDAPhysicians Total Care, Inc.1995-07-27INSULIN HUMANSUBCUTANEOUSINJECTION, SOLUTION000028215NDA0187809ec3e28a-cea9-4e45-9057-e5bf8e37014c
2647251833Novolin RNDATya Pharmaceuticals1991-06-25INSULIN HUMANSUBCUTANEOUSINJECTION, SOLUTION001691833NDA01993878dadbee-c3b6-4d62-a338-731b24cc7ef0

regular insulin, human 500 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000028501Humulin RNDAEli Lilly And Company1997-01-06INSULIN HUMANSUBCUTANEOUSINJECTION, SOLUTIONNDA018780b60e8dd0-1d48-4dc9-87fd-e14675255e8c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA018780HUMULIN RELI LILLY AND CO1982-10-28NDA018780_001, NDA018780_004, NDA018780_005
2NDA019529HUMULIN BRTrueELI LILLY AND CO1986-04-28NDA019529_001
3NDA019938NOVOLIN RNOVO NORDISK INC1991-06-25NDA019938_001
4NDA021028VELOSULIN BRTrueNOVO NORDISK INC1999-07-19NDA021028_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA018780_001OTCINSULIN RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONTrue1982-10-28HUMULIN R
2NDA018780_004RXINSULIN RECOMBINANT HUMAN (500 UNITS/ML)INJECTIONTrue1994-03-31HUMULIN R
3NDA018780_005OTCINSULIN RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONTrue1998-08-06HUMULIN R
4NDA019529_001discontinuedINSULIN RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONFalse1986-04-28HUMULIN BR
5NDA019938_001OTCINSULIN RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONTrue1991-06-25NOVOLIN R
6NDA021028_001discontinuedINSULIN RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONFalse1999-07-19VELOSULIN BR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
178dadbee-c3b6-4d62-a338-731b24cc7ef0 (view SPL)These highlights do not include all the information needed to use Novolin R safely and effectively. See full prescribing information for Novolin R. Initial U.S. Approval: 1991 Novolin R (Regular, Human Insulin [rDNA origin] USP) solution for subcutaneous or intravenous use otcHuman OTCTya PharmaceuticalsRELABEL, REPACK2013-03-092647251833
29ec3e28a-cea9-4e45-9057-e5bf8e37014c (view SPL)HUMULIN R REGULAR INSULIN HUMAN INJECTION, USP(rDNA ORIGIN)100 UNITS PER ML (U-100)otcHuman OTCPhysicians Total Care, Inc.relabel2010-11-082548683619
3aee7f1f3-612c-4027-8ce9-4fd1f41eed71 (view SPL)These highlights do not include all the information needed to use Novolin R safely and effectively. See full prescribing information for Novolin R. Novolin R (Regular, Human Insulin [rDNA origin] USP) solution for subcutaneous or intravenous use Initial U.S. Approval: 1991otcHuman OTCNovo NordiskAPI MANUFACTURE, MANUFACTURE2013-03-0912001691833
4b519bd83-038c-4ec5-a231-a51ec5cc291f (view SPL)INFORMATION FOR THE PHYSICIANHUMULIN R REGULAR INSULIN HUMAN INJECTION, USP (rDNA ORIGIN) 100 UNITS PER ML (U-100)otcHuman OTCEli Lilly And Company2015-06-3022000028215
5b60e8dd0-1d48-4dc9-87fd-e14675255e8c (view SPL)INFORMATION FOR THE PHYSICIANHUMULIN RREGULARU-500 (CONCENTRATED)INSULIN HUMAN INJECTION, USP(rDNA ORIGIN)prescriptionHuman PrescriptionEli Lilly And Company2014-09-2315000028501

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