FDA.reportPublic FDA data

Application 018780

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
018780Humulin R U-100insulin human351(a)OTC2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMULIN RINSULIN RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLNoNo
002HUMULIN R KWIKPENINSULIN HUMANSOLUTION;SUBCUTANEOUS1500 UNITS/3ML (500 UNITS/ML)NoNo
004HUMULIN RINSULIN HUMANSOLUTION;SUBCUTANEOUS10000 UNITS/20ML (500 UNITS/ML)NoNo
005HUMULIN R PENINSULIN 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humulin RINSULIN HUMANEli Lilly and Companyb519bd83-038c-4ec5-a231-a51ec5cc291f2025-05-27Warnings, Adverse reactionsExact identifier
application number: BLA018780
ndc (product): 0002-8215
Humulin R U-500INSULIN HUMANEli Lilly and Companyb60e8dd0-1d48-4dc9-87fd-e14675255e8c2024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA018780
ndc (product): 0002-8824
ndc (product): 0002-8501
HUMULIN RINSULIN HUMANA-S Medication Solutions81199e55-ade9-46de-a5a3-c0415acee4032023-10-31Warnings, Adverse reactionsExact identifier
application number: BLA018780
ndc (product): 50090-0353

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
50090-0353HumulinInsulin humanA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71482SUPPL2022-06-30
71461SUPPL2022-06-28
64284SUPPL2020-08-17
66369APPL2020-03-23
60934SUPPL2020-03-23
60933SUPPL2020-03-23
60903SUPPL2020-03-23
60901SUPPL2020-03-23
59838SUPPL2020-03-23
59822SUPPL2020-03-23
56445SUPPL2020-03-23
56370SUPPL2020-03-23
54379SUPPL2020-03-23
54378SUPPL2020-03-23
54375SUPPL2020-03-23
54374SUPPL2020-03-23
47639SUPPL2020-03-23
33601SUPPL2020-03-23
33600SUPPL2020-03-23
33599SUPPL2020-03-23
33598SUPPL2020-03-23
33597SUPPL2020-03-23
33596SUPPL2020-03-23
20158SUPPL2020-03-23
16045SUPPL2020-03-23
16044SUPPL2020-03-23
16043SUPPL2020-03-23
16042SUPPL2020-03-23
16041SUPPL2020-03-23
16040SUPPL2020-03-23
16039SUPPL2020-03-23
11330SUPPL2020-03-23
11329SUPPL2020-03-23
11328SUPPL2020-03-23
11327SUPPL2020-03-23
11326SUPPL2020-03-23
11325SUPPL2020-03-23
11324SUPPL2020-03-23
11323SUPPL2020-03-23
1078SUPPL2020-03-23
1077SUPPL2020-03-23
1076SUPPL2020-03-23
1075SUPPL2020-03-23
1074SUPPL2020-03-23
1073SUPPL2020-03-23
1072SUPPL2020-03-23
1071SUPPL2020-03-23
1070SUPPL2020-03-23
1069SUPPL2020-03-23