Home NDC 0002-8501 Humulin
Product NDC 0002-8501
11-digit product format 000028501
Labeler code 0002
Product ID 0002-8501_7872727a-5d70-410a-ad64-b3b47afceb5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Insulin human
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Eli Lilly and Company
Application BLA018780
Marketing category BLA
Marketing start 1994-03-31
Substance INSULIN HUMAN
Active strength 500 [iU]/mL
Pharmacologic classes Insulin [CS], Insulin [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-8501-01 HumulinR U-500 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 40 0002-8501-01 HumulinR U-500 1 in 1 CARTON INJECTION, SOLUTION 1 40
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Insulin human ACTIVE INGREDIENT 1Y17CTI5SR HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Insulin human ACTIVE MOIETY 1Y17CTI5SR HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Metacresol INACTIVE INGREDIENT GGO4Y809LO HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Water INACTIVE INGREDIENT 059QF0KO0R HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15 Zinc INACTIVE INGREDIENT J41CSQ7QDS HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8501 HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R U-500 KWIKPEN (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 40 Current NDC, Legacy NDC, 2 package rows 20240402_b60e8dd0-1d48-4dc9-87fd-e14675255e8c.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 · 3 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 018780 Humulin R U-100 insulin human 351(a) OTC 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1731317 HumuLIN R (concentrated) 500 UNT/ML in 3 ML Pen Injector PSN b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 351859 HumuLIN R (concentrated) 500 UNT/ML Injectable Solution PSN b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 1731315 regular insulin, human (concentrated) 500 UNT/ML in 3 ML Pen Injector PSN b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 249220 regular insulin, human (concentrated) 500 UNT/ML Injectable Solution PSN b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 1731317 3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R] SBD b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 351859 insulin, regular, human 500 UNT/ML Injectable Solution [Humulin R] SBD b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 1731315 3 ML insulin, regular, human 500 UNT/ML Pen Injector SCD b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 249220 insulin, regular, human 500 UNT/ML Injectable Solution SCD b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 1731317 3 ML Humulin R 500 UNT/ML Pen Injector SY b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 351859 Humulin R 500 UNT/ML Injectable Solution SY b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40 249220 insulin, human regular 500 UNT/ML Injectable Solution SY b60e8dd0-1d48-4dc9-87fd-e14675255e8c 40
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0002-8501-01 00002850101 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) / 20 mL in 1 VIAL, MULTI-DOSE 1997-01-06 0000-00-00 No No Current