FDA.reportPublic FDA data

Humulin

Product NDC
0002-8715
11-digit product format
000028715
Labeler code
0002
Product ID
0002-8715_c3cacc48-faa4-4b57-8cef-2ed38129604c
Type
HUMAN OTC DRUG
Nonproprietary name
Insulin human
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA019717
Marketing category
BLA
Marketing start
1989-06-26
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
70/30
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui106892, 311048, 847187, 847189

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
0002-8715-01Humulin 70/301 in 1 CARTONINJECTION, SUSPENSION148
0002-8715-01Humulin 70/3010 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1048
0002-8715-17Humulin 70/303 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION348
0002-8715-17Humulin 70/301 in 1 CARTONINJECTION, SUSPENSION148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8715-01ML - Milliliter0002-8715b1af06f5-423d-45af-9f71-7bb82f25f14612012-07-24
0002-8715-17ML - Milliliter0002-8715d6787ad8-8ae5-4c75-b069-bc0a9f46359f12012-07-24
0002-8715-91ML - Milliliter0002-8715dc363c39-842c-43ce-8a65-c806ab6e4d5712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
METACRESOLINACTIVE INGREDIENTGGO4Y809LOHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ZINCINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8715HUMULIN 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION HUMULIN 70/30 KWIKPEN (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]48Current NDC, Legacy NDC, 4 package rows20241213_e245e0c5-b2d6-418b-baa4-1c3324292885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847189HumuLIN 70/30 in 3 ML Pen InjectorPSNe245e0c5-b2d6-418b-baa4-1c332429288548
106892HumuLIN 70/30 Injectable SuspensionPSNe245e0c5-b2d6-418b-baa4-1c332429288548
847187insulin isophane, human 70 UNT/ML / insulin, human UNT/ML in 3 ML Pen InjectorPSNe245e0c5-b2d6-418b-baa4-1c332429288548
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSNe245e0c5-b2d6-418b-baa4-1c332429288548
8471893 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector [Humulin]SBDe245e0c5-b2d6-418b-baa4-1c332429288548
106892insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Humulin]SBDe245e0c5-b2d6-418b-baa4-1c332429288548
8471873 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen InjectorSCDe245e0c5-b2d6-418b-baa4-1c332429288548
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCDe245e0c5-b2d6-418b-baa4-1c332429288548
106892Humulin 70/30 Injectable SuspensionSYe245e0c5-b2d6-418b-baa4-1c332429288548
847189Humulin 70/30 per 3 ML KwikPenSYe245e0c5-b2d6-418b-baa4-1c332429288548
847187insulin isophane, human 70 UNT/ML / insulin, human UNT/ML per 3 ML Pen InjectorSYe245e0c5-b2d6-418b-baa4-1c332429288548
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSYe245e0c5-b2d6-418b-baa4-1c332429288548
106892HumuLIN 70/30 Injectable SuspensionPSN7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSN7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210
106892insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Humulin]SBD7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCD7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210
106892Humulin 70/30 Injectable SuspensionSY7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSY7f6328dc-2270-4cbd-bcb2-fb0f32a1e87210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-8715-01000028715011 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-01) / 10 mL in 1 VIAL, MULTI-DOSE1989-06-260000-00-00NoNoCurrent
0002-8715-17000028715171 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-17) > 3 mL in 1 VIAL, MULTI-DOSE2011-04-090000-00-00NoNoCurrent
0002-8715-99000028715991 VIAL, MULTI-DOSE in 1 CARTON (0002-8715-99) > 10 mL in 1 VIAL, MULTI-DOSE1993-08-060000-00-00YesNoCurrent