FDA.reportPublic FDA data

Humulin

Product NDC
0002-8824
11-digit product format
000028824
Labeler code
0002
Product ID
0002-8824_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
2015-12-29
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

Additional Listing Data#

Finished product
Yes
Brand name base
Humulin
Brand name suffix
R U-500 KwikPen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN500 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui249220, 351859, 1731315, 1731317

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
0002-8824-27HumulinR U-500 KwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION340
0002-8824-27HumulinR U-500 KwikPen2 in 1 CARTONINJECTION, SOLUTION240

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8824-27ML - Milliliter0002-882414f05a9c-4555-42f6-af00-5b698491277112016-02-04

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
0002-8824HUMULIN 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

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8824-27000028824272 SYRINGE in 1 CARTON (0002-8824-27) / 3 mL in 1 SYRINGE2 syringe2016-03-250000-00-00NoNoCurrent