Home NDC 0002-8805 Humulin
Product NDC 0002-8805
11-digit product format 000028805
Labeler code 0002
Product ID 0002-8805_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 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 N
Listing expiration 2026-12-31 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 311026 Internal RxNorm lookup 311028 Internal RxNorm lookup 847199 Internal RxNorm lookup 1654862 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 0002-8805-01 Humulin N 3 mL in 1 SYRINGE INJECTION, SUSPENSION 3 50 0002-8805-59 Humulin N 5 in 1 CARTON INJECTION, SUSPENSION 5 50
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8805 HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY] 47 Current NDC, Legacy NDC, 2 package rows 20240823_f6edd793-440b-40c2-96b5-c16133b7a921.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 018781 Humulin N insulin isophane human 351(a) OTC 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 847199 HumuLIN N 100 UNT/ML in 3 ML Pen Injector PSN f6edd793-440b-40c2-96b5-c16133b7a921 50 311026 HumuLIN N 100 UNT/ML Injectable Suspension PSN f6edd793-440b-40c2-96b5-c16133b7a921 50 1654862 insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector PSN f6edd793-440b-40c2-96b5-c16133b7a921 50 311028 insulin isophane (NPH), human 100 UNT/mL Injectable Suspension PSN f6edd793-440b-40c2-96b5-c16133b7a921 50 847199 3 ML insulin isophane, human 100 UNT/ML Pen Injector [Humulin N] SBD f6edd793-440b-40c2-96b5-c16133b7a921 50 311026 insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N] SBD f6edd793-440b-40c2-96b5-c16133b7a921 50 1654862 3 ML insulin isophane, human 100 UNT/ML Pen Injector SCD f6edd793-440b-40c2-96b5-c16133b7a921 50 311028 insulin isophane, human 100 UNT/ML Injectable Suspension SCD f6edd793-440b-40c2-96b5-c16133b7a921 50 847199 3 ML Humulin N 100 UNT/ML Pen Injector SY f6edd793-440b-40c2-96b5-c16133b7a921 50 847199 Humulin N (insulin isophane (NPH), human) 100 UNT/ML per 3 ML KwikPen SY f6edd793-440b-40c2-96b5-c16133b7a921 50 311026 Humulin N 100 UNT/ML Injectable Suspension SY f6edd793-440b-40c2-96b5-c16133b7a921 50 311028 insulin isophane (NPH), human 100 UNT/ML Injectable Suspension SY f6edd793-440b-40c2-96b5-c16133b7a921 50 1654862 insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector SY f6edd793-440b-40c2-96b5-c16133b7a921 50 1654862 insulin isophane U-100 per 3 ML Pen Injector SY f6edd793-440b-40c2-96b5-c16133b7a921 50
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0002-8805-01 00002880501 3 mL in 1 SYRINGE 3 ml Historical 0002-8805-59 00002880559 5 SYRINGE in 1 CARTON (0002-8805-59) / 3 mL in 1 SYRINGE (0002-8805-01) 5 syringe 2014-01-17 0000-00-00 No No Current 0002-8805-99 00002880599 1 SYRINGE in 1 CARTON (0002-8805-99) > 3 mL in 1 SYRINGE 1 syringe 2013-11-07 0000-00-00 Yes No Current