Humulin

Product NDC
0002-8315
11-digit product format
000028315
Labeler code
0002
Product ID
0002-8315_79bc67f8-8bf8-4e92-bdd9-3e0700e6d9db
Type
HUMAN OTC DRUG
Nonproprietary name
Insulin human
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA018781
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
N
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui311026, 311028, 847199, 1654862

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
0002-8315-01Humulin N1 in 1 CARTONINJECTION, SUSPENSION150
0002-8315-01Humulin N10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1050

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8315HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]47Current NDC, Legacy NDC, 2 package rows20240823_f6edd793-440b-40c2-96b5-c16133b7a921.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847199HumuLIN N 100 UNT/ML in 3 ML Pen InjectorPSNf6edd793-440b-40c2-96b5-c16133b7a92150
311026HumuLIN N 100 UNT/ML Injectable SuspensionPSNf6edd793-440b-40c2-96b5-c16133b7a92150
1654862insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen InjectorPSNf6edd793-440b-40c2-96b5-c16133b7a92150
311028insulin isophane (NPH), human 100 UNT/mL Injectable SuspensionPSNf6edd793-440b-40c2-96b5-c16133b7a92150
8471993 ML insulin isophane, human 100 UNT/ML Pen Injector [Humulin N]SBDf6edd793-440b-40c2-96b5-c16133b7a92150
311026insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]SBDf6edd793-440b-40c2-96b5-c16133b7a92150
16548623 ML insulin isophane, human 100 UNT/ML Pen InjectorSCDf6edd793-440b-40c2-96b5-c16133b7a92150
311028insulin isophane, human 100 UNT/ML Injectable SuspensionSCDf6edd793-440b-40c2-96b5-c16133b7a92150
8471993 ML Humulin N 100 UNT/ML Pen InjectorSYf6edd793-440b-40c2-96b5-c16133b7a92150
847199Humulin N (insulin isophane (NPH), human) 100 UNT/ML per 3 ML KwikPenSYf6edd793-440b-40c2-96b5-c16133b7a92150
311026Humulin N 100 UNT/ML Injectable SuspensionSYf6edd793-440b-40c2-96b5-c16133b7a92150
311028insulin isophane (NPH), human 100 UNT/ML Injectable SuspensionSYf6edd793-440b-40c2-96b5-c16133b7a92150
1654862insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen InjectorSYf6edd793-440b-40c2-96b5-c16133b7a92150
1654862insulin isophane U-100 per 3 ML Pen InjectorSYf6edd793-440b-40c2-96b5-c16133b7a92150
311026HumuLIN N 100 UNT/ML Injectable SuspensionPSN456e226e-e7b0-4850-b649-3d9e5533893c12
311028insulin isophane (NPH), human 100 UNT/mL Injectable SuspensionPSN456e226e-e7b0-4850-b649-3d9e5533893c12
311026insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]SBD456e226e-e7b0-4850-b649-3d9e5533893c12
311028insulin isophane, human 100 UNT/ML Injectable SuspensionSCD456e226e-e7b0-4850-b649-3d9e5533893c12
311026Humulin N 100 UNT/ML Injectable SuspensionSY456e226e-e7b0-4850-b649-3d9e5533893c12
311028insulin isophane (NPH), human 100 UNT/ML Injectable SuspensionSY456e226e-e7b0-4850-b649-3d9e5533893c12
311026HumuLIN N 100 UNT/ML Injectable SuspensionPSN81f28314-31c8-4114-a4b3-336eb20945581
311028insulin isophane (NPH), human 100 UNT/mL Injectable SuspensionPSN81f28314-31c8-4114-a4b3-336eb20945581
311026insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]SBD81f28314-31c8-4114-a4b3-336eb20945581
311028insulin isophane, human 100 UNT/ML Injectable SuspensionSCD81f28314-31c8-4114-a4b3-336eb20945581
311026Humulin N 100 UNT/ML Injectable SuspensionSY81f28314-31c8-4114-a4b3-336eb20945581
311028insulin isophane (NPH), human 100 UNT/ML Injectable SuspensionSY81f28314-31c8-4114-a4b3-336eb20945581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-8315-01000028315011 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-01) / 10 mL in 1 VIAL, MULTI-DOSE1983-06-270000-00-00NoNoCurrent
0002-8315-17000028315171 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-17) > 3 mL in 1 VIAL, MULTI-DOSE2010-06-240000-00-00NoNoCurrent
0002-8315-99000028315991 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-99) > 10 mL in 1 VIAL, MULTI-DOSE1983-06-270000-00-00YesNoCurrent