FDA.reportPublic FDA data

Humulin

Product NDC
0002-8501
Requested package NDC
0002-8501-01
11-digit product format
000028501
Labeler code
0002
Product ID
0002-8501_7872727a-5d70-410a-ad64-b3b47afceb5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin human
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA018780
Marketing category
BLA
Marketing start
1994-03-31
Substance
INSULIN HUMAN
Active strength
500 [iU]/mL
Pharmacologic classes
Insulin [CS], Insulin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0002-85010002-8501-01DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8501-01HumulinR U-50020 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2040
0002-8501-01HumulinR U-5001 in 1 CARTONINJECTION, SOLUTION140

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8501-01ML - Milliliter0002-85017439ef81-9347-4bc5-86f5-6662e78e935112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin humanACTIVE INGREDIENT1Y17CTI5SRHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
Insulin humanACTIVE MOIETY1Y17CTI5SRHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
WaterINACTIVE INGREDIENT059QF0KO0RHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8501HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R U-500 KWIKPEN (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY]40Current NDC, Legacy NDC, 2 package rows20240402_b60e8dd0-1d48-4dc9-87fd-e14675255e8c.zip

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 R U-500 KwikPenINSULIN HUMANEli Lilly and Companyb60e8dd0-1d48-4dc9-87fd-e14675255e8c2026-07-01Warnings, Adverse reactionsExact identifier
application number: BLA018780
ndc (package): 0002-8501-01
ndc (product): 0002-8501
ndc11 (package): 00002850101
Humulin RINSULIN HUMANEli Lilly and Companyb519bd83-038c-4ec5-a231-a51ec5cc291f2026-06-16Warnings, Adverse reactionsExact identifier
application number: BLA018780
HUMULIN RINSULIN HUMANA-S Medication Solutions81199e55-ade9-46de-a5a3-c0415acee4032023-10-31Warnings, Adverse reactionsExact identifier
application number: BLA018780

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
018780Humulin R U-100insulin human351(a)OTC2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731317HumuLIN R (concentrated) 500 UNT/ML in 3 ML Pen InjectorPSNb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
351859HumuLIN R (concentrated) 500 UNT/ML Injectable SolutionPSNb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
1731315regular insulin, human (concentrated) 500 UNT/ML in 3 ML Pen InjectorPSNb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
249220regular insulin, human (concentrated) 500 UNT/ML Injectable SolutionPSNb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
17313173 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]SBDb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
351859insulin, regular, human 500 UNT/ML Injectable Solution [Humulin R]SBDb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
17313153 ML insulin, regular, human 500 UNT/ML Pen InjectorSCDb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
249220insulin, regular, human 500 UNT/ML Injectable SolutionSCDb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
17313173 ML Humulin R 500 UNT/ML Pen InjectorSYb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
351859Humulin R 500 UNT/ML Injectable SolutionSYb60e8dd0-1d48-4dc9-87fd-e14675255e8c40
249220insulin, human regular 500 UNT/ML Injectable SolutionSYb60e8dd0-1d48-4dc9-87fd-e14675255e8c40

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-8501-01000028501011 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) / 20 mL in 1 VIAL, MULTI-DOSE1997-01-060000-00-00NoNoCurrent