Home NDC 0002-8315 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 0002-8315-01 Humulin N 1 in 1 CARTON INJECTION, SUSPENSION 1 50 0002-8315-01 Humulin N 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 10 50
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INSULIN HUMAN ACTIVE INGREDIENT 1Y17CTI5SR HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 INSULIN HUMAN ACTIVE MOIETY 1Y17CTI5SR HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 METACRESOL INACTIVE INGREDIENT GGO4Y809LO HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 PROTAMINE SULFATE INACTIVE INGREDIENT 0DE9724IHC HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ZINC INACTIVE INGREDIENT J41CSQ7QDS HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8315 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 311026 HumuLIN N 100 UNT/ML Injectable Suspension PSN 456e226e-e7b0-4850-b649-3d9e5533893c 12 311028 insulin isophane (NPH), human 100 UNT/mL Injectable Suspension PSN 456e226e-e7b0-4850-b649-3d9e5533893c 12 311026 insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N] SBD 456e226e-e7b0-4850-b649-3d9e5533893c 12 311028 insulin isophane, human 100 UNT/ML Injectable Suspension SCD 456e226e-e7b0-4850-b649-3d9e5533893c 12 311026 Humulin N 100 UNT/ML Injectable Suspension SY 456e226e-e7b0-4850-b649-3d9e5533893c 12 311028 insulin isophane (NPH), human 100 UNT/ML Injectable Suspension SY 456e226e-e7b0-4850-b649-3d9e5533893c 12 311026 HumuLIN N 100 UNT/ML Injectable Suspension PSN 81f28314-31c8-4114-a4b3-336eb2094558 1 311028 insulin isophane (NPH), human 100 UNT/mL Injectable Suspension PSN 81f28314-31c8-4114-a4b3-336eb2094558 1 311026 insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N] SBD 81f28314-31c8-4114-a4b3-336eb2094558 1 311028 insulin isophane, human 100 UNT/ML Injectable Suspension SCD 81f28314-31c8-4114-a4b3-336eb2094558 1 311026 Humulin N 100 UNT/ML Injectable Suspension SY 81f28314-31c8-4114-a4b3-336eb2094558 1 311028 insulin isophane (NPH), human 100 UNT/ML Injectable Suspension SY 81f28314-31c8-4114-a4b3-336eb2094558 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0002-8315-01 00002831501 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-01) / 10 mL in 1 VIAL, MULTI-DOSE 1983-06-27 0000-00-00 No No Current 0002-8315-17 00002831517 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-17) > 3 mL in 1 VIAL, MULTI-DOSE 2010-06-24 0000-00-00 No No Current 0002-8315-99 00002831599 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-99) > 10 mL in 1 VIAL, MULTI-DOSE 1983-06-27 0000-00-00 Yes No Current