Home NDC 0002-8803 Humulin
Product NDC 0002-8803
11-digit product format 000028803
Labeler code 0002
Product ID 0002-8803_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 2013-11-07
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 KwikPen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INSULIN HUMAN 100 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y17CTI5SR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106892 Internal RxNorm lookup 311048 Internal RxNorm lookup 847187 Internal RxNorm lookup 847189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-8803-01 Humulin 70/30 KwikPen 3 mL in 1 SYRINGE INJECTION, SUSPENSION 3 48 0002-8803-59 Humulin 70/30 KwikPen 5 in 1 CARTON INJECTION, SUSPENSION 5 48
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8803 HUMULIN 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION HUMULIN 70/30 KWIKPEN (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY] 48 Current NDC, Legacy NDC, 2 package rows 20241213_e245e0c5-b2d6-418b-baa4-1c3324292885.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 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019717 Humulin 70/30 insulin isophane human and insulin human 351(a) OTC 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 847189 HumuLIN 70/30 in 3 ML Pen Injector PSN e245e0c5-b2d6-418b-baa4-1c3324292885 48 106892 HumuLIN 70/30 Injectable Suspension PSN e245e0c5-b2d6-418b-baa4-1c3324292885 48 847187 insulin isophane, human 70 UNT/ML / insulin, human UNT/ML in 3 ML Pen Injector PSN e245e0c5-b2d6-418b-baa4-1c3324292885 48 311048 insulin, human isophane / insulin regular 70/30 Injectable Suspension PSN e245e0c5-b2d6-418b-baa4-1c3324292885 48 847189 3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector [Humulin] SBD e245e0c5-b2d6-418b-baa4-1c3324292885 48 106892 insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Humulin] SBD e245e0c5-b2d6-418b-baa4-1c3324292885 48 847187 3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector SCD e245e0c5-b2d6-418b-baa4-1c3324292885 48 311048 insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension SCD e245e0c5-b2d6-418b-baa4-1c3324292885 48 106892 Humulin 70/30 Injectable Suspension SY e245e0c5-b2d6-418b-baa4-1c3324292885 48 847189 Humulin 70/30 per 3 ML KwikPen SY e245e0c5-b2d6-418b-baa4-1c3324292885 48 847187 insulin isophane, human 70 UNT/ML / insulin, human UNT/ML per 3 ML Pen Injector SY e245e0c5-b2d6-418b-baa4-1c3324292885 48 311048 insulin, human mixed 70/30 100 UNT/ML Injectable Suspension SY e245e0c5-b2d6-418b-baa4-1c3324292885 48
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0002-8803-01 00002880301 3 mL in 1 SYRINGE 3 ml Historical 0002-8803-59 00002880359 5 SYRINGE in 1 CARTON (0002-8803-59) / 3 mL in 1 SYRINGE (0002-8803-01) 5 syringe 2014-01-17 0000-00-00 No No Current 0002-8803-61 00002880361 1 SYRINGE in 1 CARTON (0002-8803-61) > 3 mL in 1 SYRINGE 1 syringe 2015-04-29 0000-00-00 Yes No Current