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)OTC2026-06-01

Application Products#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, 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