FDA.reportPublic FDA data

NDC 0002-8799-01 - Humalog

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0002-8799
Requested NDC
0002-8799-01
Package NDCs from labels
0002-8799-01, 0002-8799-59
Manufacturer
Eli Lilly and Company
Effective date
2026-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Humalog - Eli Lilly and CompanyEli Lilly and Company2026-06-16HUMAN PRESCRIPTION DRUG LABEL
HUMALOG - A-S Medication SolutionsA-S Medication Solutions2025-04-01HUMAN PRESCRIPTION DRUG LABEL
Humalog KwikPen - A-S Medication SolutionsA-S Medication Solutions2024-01-24HUMAN PRESCRIPTION DRUG LABEL
Humalog KwikPen - REMEDYREPACK INC.REMEDYREPACK INC.2022-01-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
0002-8799-59These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996
0002-8799-59These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996
0002-8799-61These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996
0002-8799-61These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8799-01HumalogKwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION386
0002-8799-59HumalogKwikPen5 in 1 CARTONINJECTION, SOLUTION586
0002-8799-61HumalogKwikPen1 in 1 CARTONINJECTION, SOLUTION186
0002-8799-61HumalogKwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION386

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8799HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION STERILE DILUENT (DILUENT) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]84Current NDC, Legacy NDC, 4 package rows20250523_c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8799-01ML - Milliliter0002-879957778c30-09bb-4973-bf6e-a588ce5e959012012-07-24
0002-8799-59ML - Milliliter0002-879999c49b1b-fb95-492e-b6f8-9f944d3d0c5112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
TromethamineINACTIVE INGREDIENT023C2WHX2VHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]49

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 16 of 44 · 862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
unii: 339NCG44TV
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
unii: 339NCG44TV
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
unii: 339NCG44TV
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
unii: 339NCG44TV
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.