FDA.reportPublic FDA data

Humulin

Product NDC
0002-8215
11-digit product format
000028215
Labeler code
0002
Product ID
0002-8215_42527ae4-c593-4e13-8b77-c0511198c708
Type
HUMAN OTC DRUG
Nonproprietary name
Insulin human
Dosage form
INJECTION, SOLUTION
Route
PARENTERAL
Labeler
Eli Lilly and Company
Application
BLA018780
Marketing category
BLA
Marketing start
1983-06-27
Substance
INSULIN HUMAN
Active strength
100 [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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui311034, 311036

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
0002-8215-01Humulin R1 in 1 CARTONINJECTION, SOLUTION134
0002-8215-01Humulin R10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1034
0002-8215-17Humulin R3 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION334
0002-8215-17Humulin R1 in 1 CARTONINJECTION, SOLUTION134

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8215-01ML - Milliliter0002-82158ca48fdc-9056-4117-a82a-4abbf5d047ee12012-07-24
0002-8215-17ML - Milliliter0002-8215fb28a7eb-efcf-4905-9fd3-3a5ff4f5261712012-07-24
0002-8215-91ML - Milliliter0002-8215deb19078-1ada-4f89-9cb2-45a4a272a2c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin humanACTIVE INGREDIENT1Y17CTI5SRHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
insulin humanACTIVE MOIETY1Y17CTI5SRHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
glycerinINACTIVE INGREDIENTPDC6A3C0OXHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
WaterINACTIVE INGREDIENT059QF0KO0RHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]22
insulin humanACTIVE INGREDIENT1Y17CTI5SRHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
insulin humanACTIVE MOIETY1Y17CTI5SRHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RHUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8215HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY]33Current NDC, Legacy NDC, 4 package rows20230913_b519bd83-038c-4ec5-a231-a51ec5cc291f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311036HumuLIN R 100 UNT/ML Injectable SolutionPSNb519bd83-038c-4ec5-a231-a51ec5cc291f34
311034regular insulin, human 100 UNT/ML Injectable SolutionPSNb519bd83-038c-4ec5-a231-a51ec5cc291f34
311036insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R]SBDb519bd83-038c-4ec5-a231-a51ec5cc291f34
311034insulin, regular, human 100 UNT/ML Injectable SolutionSCDb519bd83-038c-4ec5-a231-a51ec5cc291f34
311036Humulin R 100 UNT/ML Injectable SolutionSYb519bd83-038c-4ec5-a231-a51ec5cc291f34
311034insulin, human regular 100 UNT/ML Injectable SolutionSYb519bd83-038c-4ec5-a231-a51ec5cc291f34
311036HumuLIN R 100 UNT/ML Injectable SolutionPSN81199e55-ade9-46de-a5a3-c0415acee40325
311034regular insulin, human 100 UNT/ML Injectable SolutionPSN81199e55-ade9-46de-a5a3-c0415acee40325
311036insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R]SBD81199e55-ade9-46de-a5a3-c0415acee40325
311034insulin, regular, human 100 UNT/ML Injectable SolutionSCD81199e55-ade9-46de-a5a3-c0415acee40325
311036Humulin R 100 UNT/ML Injectable SolutionSY81199e55-ade9-46de-a5a3-c0415acee40325
311034insulin, human regular 100 UNT/ML Injectable SolutionSY81199e55-ade9-46de-a5a3-c0415acee40325
311036HumuLIN R 100 UNT/ML Injectable SolutionPSN9ec3e28a-cea9-4e45-9057-e5bf8e37014c2
311034regular insulin, human 100 UNT/ML Injectable SolutionPSN9ec3e28a-cea9-4e45-9057-e5bf8e37014c2
311036insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R]SBD9ec3e28a-cea9-4e45-9057-e5bf8e37014c2
311034insulin, regular, human 100 UNT/ML Injectable SolutionSCD9ec3e28a-cea9-4e45-9057-e5bf8e37014c2
311036Humulin R 100 UNT/ML Injectable SolutionSY9ec3e28a-cea9-4e45-9057-e5bf8e37014c2
311034insulin, human regular 100 UNT/ML Injectable SolutionSY9ec3e28a-cea9-4e45-9057-e5bf8e37014c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-8215-01000028215011 VIAL, MULTI-DOSE in 1 CARTON (0002-8215-01) / 10 mL in 1 VIAL, MULTI-DOSE1983-06-270000-00-00NoNoCurrent
0002-8215-17000028215171 VIAL, MULTI-DOSE in 1 CARTON (0002-8215-17) / 3 mL in 1 VIAL, MULTI-DOSE2009-12-042026-08-11NoNoCurrent
0002-8215-99000028215991 VIAL, MULTI-DOSE in 1 CARTON (0002-8215-99) > 10 mL in 1 VIAL, MULTI-DOSE1999-01-310000-00-00YesNoCurrent