insulin, isophane Injectable Suspension

Brand(s)
Humulin N, Novolin N
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Novo Nordisk (2015-02-25)
Oldest Current Product
1991-07-01
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\INSULIN, ISOPHANE
FDAOB
INJECTION\INJECTION\INSULIN SUSP ISOPHANE RECOMBINANT HUMAN\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SUSPENSION\INSULIN HUMAN
SPL Moiety
SUBCUTANEOUS\INJECTION, SUSPENSION\INSULIN HUMAN

product(s) by strength(s)

insulin human, isophane 100 unt/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001691834Novolin NNDANovo Nordisk1991-07-01INSULIN HUMANSUBCUTANEOUSINJECTION, SUSPENSIONNDA01995982f1445c-b2c6-445a-82cf-ba8825fac776

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681429Humulin NNDAPhysicians Total Care, Inc.1994-10-24INSULIN HUMANSUBCUTANEOUSINJECTION, SUSPENSION000028315NDA01878181f28314-31c8-4114-a4b3-336eb2094558
2647251834Novolin NNDATya Pharmaceuticals1991-07-01INSULIN HUMANSUBCUTANEOUSINJECTION, SUSPENSION001691834NDA01995999c995f1-522e-42aa-b45a-117e0af77d81

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA018781HUMULIN NELI LILLY AND CO1982-10-28p7291132, SUBSTANCENDA018781_001
2NDA019959NOVOLIN NNOVO NORDISK INC1991-07-01NDA019959_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA018781_001OTCINSULIN SUSP ISOPHANE RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONTrue1982-10-28HUMULIN N
2NDA019959_001OTCINSULIN SUSP ISOPHANE RECOMBINANT HUMAN (100 UNITS/ML)INJECTIONTrue1991-07-01NOVOLIN N

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7291132 (view patent)2024-08-09NDA018781, NDA019717, NDA020563, NDA021017, NDA021018, NDA205747insulin, isophane / Regular Insulin, Human Injectable Suspension
Insulin Lispro / Insulin, Protamine Lispro, Human Injectable Suspension
Insulin Lispro Injectable Solution
Insulin Lispro Cartridge
Insulin Lispro Pen Injector
Insulin Lispro / Insulin, Protamine Lispro, Human Pen Injector

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
181f28314-31c8-4114-a4b3-336eb2094558 (view SPL)otcHuman OTCPhysicians Total Care, Inc.relabel2010-11-081548681429
282f1445c-b2c6-445a-82cf-ba8825fac776 (view SPL)Novolin N NPH, Human Insulin Isophane Suspension (recombinant DNA origin) 100 units/mLotcHuman OTCNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-02-2510001691834
399c995f1-522e-42aa-b45a-117e0af77d81 (view SPL)Novolin N NPH, Human Insulin Isophane Suspension (recombinant DNA origin) 100 units/mLotcHuman OTCTya PharmaceuticalsRELABEL, REPACK2013-08-272647251834
4f6edd793-440b-40c2-96b5-c16133b7a921 (view SPL)These highlights do not include all the information needed to use HUMULINN safely and effectively. See full prescribing information for HUMULINN.HUMULIN N (human insulin [rDNA origin] isophane suspension), injectable suspension, for subcutaneous useInitial U.S. Approval: 1982otcHuman OTCEli Lilly And Company2015-09-2427000028315, 000028730, 000028805insulin, isophane Pen Injector

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