FDA.reportPublic FDA data

Application 018781

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
018781Humulin Ninsulin isophane human351(a)OTC2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMULIN NINSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
ndc (product): 0002-0800
Humulin NINSULIN HUMANEli Lilly and Companyf6edd793-440b-40c2-96b5-c16133b7a9212025-12-19Warnings, Adverse reactionsExact identifier
application number: BLA018781
ndc (product): 0002-8805
ndc (product): 0002-8315

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-0800Sterile DiluentdiluentEli Lilly and CompanyBLACurrent
0002-0800Sterile DiluentdiluentEli Lilly and CompanyNDACurrent
0002-0800Sterile DiluentdiluentEli Lilly and CompanyNDACurrent
0002-0800Sterile DiluentdiluentEli Lilly and CompanyBLACurrent
0002-0800Sterile DiluentdiluentEli Lilly and CompanyNDACurrent
0002-0800Sterile DiluentdiluentEli Lilly and CompanyBLACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8315HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8805HumulinInsulin humanEli Lilly and CompanyBLACurrent
50090-0352HumulinInsulin humanA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71483SUPPL2022-06-30
71459SUPPL2022-06-28
60932SUPPL2020-03-23
60931SUPPL2020-03-23
60897SUPPL2020-03-23
60896SUPPL2020-03-23
59837SUPPL2020-03-23
59823SUPPL2020-03-23
56446SUPPL2020-03-23
56380SUPPL2020-03-23
46788SUPPL2020-03-23
46732SUPPL2020-03-23
33606SUPPL2020-03-23
33605SUPPL2020-03-23
33604SUPPL2020-03-23
33603SUPPL2020-03-23
33602SUPPL2020-03-23
20159SUPPL2020-03-23
16054SUPPL2020-03-23
16053SUPPL2020-03-23
16052SUPPL2020-03-23
16051SUPPL2020-03-23
16050SUPPL2020-03-23
16049SUPPL2020-03-23
16048SUPPL2020-03-23
16047SUPPL2020-03-23
16046SUPPL2020-03-23
11341SUPPL2020-03-23
11340SUPPL2020-03-23
11339SUPPL2020-03-23
11338SUPPL2020-03-23
11337SUPPL2020-03-23
11336SUPPL2020-03-23
11335SUPPL2020-03-23
11334SUPPL2020-03-23
11333SUPPL2020-03-23
11332SUPPL2020-03-23
11331SUPPL2020-03-23
1090SUPPL2020-03-23
1089SUPPL2020-03-23
1088SUPPL2020-03-23
1087SUPPL2020-03-23
1086SUPPL2020-03-23
1085SUPPL2020-03-23
1084SUPPL2020-03-23
1083SUPPL2020-03-23
1082SUPPL2020-03-23
1081SUPPL2020-03-23
1080SUPPL2020-03-23
1079SUPPL2020-03-23
66372APPL2020-03-22