FDA.reportPublic FDA data

Application 020563

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020563Humaloginsulin lispro351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMALOGINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
002HUMALOG PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
003HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLNoNo
004HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION200UNITS/MLNoNo
005HUMALOG TEMPO PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100UNITS/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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 0002-7510
ndc (product): 0002-7516
ndc (product): 0002-8213
ndc (product): 0002-8799
ndc (product): 0002-7714
Insulin LisproINSULIN LISPROEli Lilly and Company97d5e596-aae1-42c9-ae89-c3780959c4672025-06-17Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 0002-8222
ndc (product): 0002-7737
ndc (product): 0002-7752
HUMALOGINSULIN LISPROA-S Medication Solutionsc6b8ff07-d3e2-457f-8a38-b60de60adf752025-04-01Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 50090-1375
ndc (product): 50090-1663
Insulin LisproINSULIN LISPROA-S Medication Solutions2be14cbb-197a-4da8-82c8-2443594e7f6f2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 50090-5391
HUMALOGINSULIN LISPROA-S Medication Solutions6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c2024-02-15Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 50090-4488
Humalog KwikPenINSULIN LISPROA-S Medication Solutions51d3dc11-52b9-4296-a2f4-58c770d4448d2024-01-24Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 50090-4073

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7510HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7516HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7714HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7737Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7737Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7737Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7737Insulin LisproInsulin lisproEli Lilly and CompanyNDA AUTHORIZED GENERICCurrent
0002-7752Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7752Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7752Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-7752Insulin LisproInsulin lisproEli Lilly and CompanyNDA AUTHORIZED GENERICCurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8213HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8222Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-8222Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-8222Insulin LisproInsulin lisproEli Lilly and CompanyBLACurrent
0002-8222Insulin LisproInsulin lisproEli Lilly and CompanyNDA AUTHORIZED GENERICCurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8799HumalogInsulin lisproEli Lilly and CompanyNDACurrent
50090-1375HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-1375HumalogInsulin lisproA-S Medication SolutionsNDACurrent
50090-1375HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-1663HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-1663HumalogInsulin lisproA-S Medication SolutionsNDACurrent
50090-1663HumalogInsulin lisproA-S Medication SolutionsNDACurrent
50090-4073HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-4073HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-4488HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-4488HumalogInsulin lisproA-S Medication SolutionsBLACurrent
50090-4488HumalogInsulin lisproA-S Medication SolutionsNDACurrent
50090-5391Insulin LisproInsulin lisproA-S Medication SolutionsBLACurrent
55045-3602HumalogInsulin lisproDispensing Solutions, Inc.NDACurrent
66733-773Insulin lisproInsulin LisproImClone LLCBLACurrent
66733-773Insulin lisproInsulin LisproImClone LLCNDA AUTHORIZED GENERICCurrent
66733-773Insulin lisproInsulin LisproImClone LLCNDA AUTHORIZED GENERICCurrent
66733-822Insulin LisproInsulin lisproImClone LLCBLACurrent
66733-822Insulin LisproInsulin lisproImClone LLCNDA AUTHORIZED GENERICCurrent
66733-822Insulin LisproInsulin lisproImClone LLCNDA AUTHORIZED GENERICCurrent
70518-1388HumalogInsulin lisproREMEDYREPACK INC.NDACurrent
70518-1388HumalogInsulin lisproREMEDYREPACK INC.BLACurrent
70518-1388HumalogInsulin lisproREMEDYREPACK INC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82184SUPPL 2025-05-14
82258SUPPL 2025-05-07
74876SUPPL 2024-05-28
74870SUPPL 2023-07-24
66376APPL2020-03-23
60923SUPPL2020-03-23
60921SUPPL2020-03-23
60919SUPPL2020-03-23
60864SUPPL2020-03-23
60863SUPPL2020-03-23
60862SUPPL2020-03-23
59698SUPPL2020-03-23
59696SUPPL2020-03-23
57662ORIG2020-03-23
57206SUPPL2020-03-23
56840SUPPL2020-03-23
56715SUPPL2020-03-23
56293SUPPL2020-03-23
56247SUPPL2020-03-23
48670SUPPL2020-03-23
48665SUPPL2020-03-23
46791SUPPL2020-03-23
46765SUPPL2020-03-23
41434SUPPL2020-03-23
41433SUPPL2020-03-23
34852SUPPL2020-03-23
34851SUPPL2020-03-23
34850SUPPL2020-03-23
34849SUPPL2020-03-23
34848SUPPL2020-03-23
34847SUPPL2020-03-23
34846SUPPL2020-03-23
34845SUPPL2020-03-23
34844SUPPL2020-03-23
34843SUPPL2020-03-23
34842SUPPL2020-03-23
34841SUPPL2020-03-23
34840SUPPL2020-03-23
34839SUPPL2020-03-23
25195SUPPL2020-03-23
25194SUPPL2020-03-23
25193SUPPL2020-03-23
25192SUPPL2020-03-23
25191SUPPL2020-03-23
25190SUPPL2020-03-23
25189SUPPL2020-03-23
25188SUPPL2020-03-23
25187SUPPL2020-03-23
25186SUPPL2020-03-23
25185SUPPL2020-03-23
25184SUPPL2020-03-23
12744SUPPL2020-03-23
12743SUPPL2020-03-23
12742SUPPL2020-03-23
12741SUPPL2020-03-23
12740SUPPL2020-03-23
12739SUPPL2020-03-23
12738SUPPL2020-03-23
12737SUPPL2020-03-23
12736SUPPL2020-03-23
12735SUPPL2020-03-23
12734SUPPL2020-03-23
12733SUPPL2020-03-23
12732SUPPL2020-03-23
12731SUPPL2020-03-23
2747SUPPL2020-03-23
2746SUPPL2020-03-23
2745SUPPL2020-03-23
2744SUPPL2020-03-23
2743SUPPL2020-03-23
2742SUPPL2020-03-23
2741SUPPL2020-03-23
2740SUPPL2020-03-23
2739SUPPL2020-03-23
2738SUPPL2020-03-23
2737SUPPL2020-03-23
2736SUPPL2020-03-23
2735SUPPL2020-03-23
2734SUPPL2020-03-23
2733SUPPL2020-03-23
2732SUPPL2020-03-23