Home NDC 0169-3004-15 Novolin
Product NDC 0169-3004
Requested package NDC 0169-3004-15
11-digit product format 001693004
Labeler code 0169
Product ID 0169-3004_652d3fd6-809f-476e-9159-a1beffb9ea01
Type HUMAN OTC DRUG
Nonproprietary name Human Insulin
Dosage form INJECTION, SUSPENSION
Route SUBCUTANEOUS
Labeler Novo Nordisk
Application BLA019959
Marketing category BLA
Marketing start 2019-09-06
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 Novolin
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 311027 Internal RxNorm lookup 311028 Internal RxNorm lookup 1654862 Internal RxNorm lookup 2206099 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 0169-3004-01 NovolinN 3 mL in 1 SYRINGE, PLASTIC INJECTION, SUSPENSION 3 17 0169-3004-12 NovolinN 3 mL in 1 SYRINGE, PLASTIC INJECTION, SUSPENSION 3 17 0169-3004-15 NovolinN 5 in 1 CARTON INJECTION, SUSPENSION 5 17 0169-3004-25 NovolinN 5 in 1 CARTON INJECTION, SUSPENSION 5 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INSULIN HUMAN ACTIVE INGREDIENT 1Y17CTI5SR NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 INSULIN HUMAN ACTIVE MOIETY 1Y17CTI5SR NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 METACRESOL INACTIVE INGREDIENT GGO4Y809LO NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 PHENOL INACTIVE INGREDIENT 339NCG44TV NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 PROTAMINE SULFATE INACTIVE INGREDIENT 0DE9724IHC NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 WATER INACTIVE INGREDIENT 059QF0KO0R NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10 ZINC CHLORIDE INACTIVE INGREDIENT 86Q357L16B NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-3004 NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] 17 Current NDC, Legacy NDC, 4 package rows 20221208_82f1445c-b2c6-445a-82cf-ba8825fac776.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 019959 Novolin N insulin isophane human 351(a) OTC 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1654862 insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector PSN 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311028 insulin isophane (NPH), human 100 UNT/mL Injectable Suspension PSN 82f1445c-b2c6-445a-82cf-ba8825fac776 17 2206099 NovoLIN N 100 UNT/mL in 3 mL Pen Injector PSN 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311027 NovoLIN N 100 UNT/ML Injectable Suspension PSN 82f1445c-b2c6-445a-82cf-ba8825fac776 17 2206099 3 ML insulin isophane, human 100 UNT/ML Pen Injector [Novolin N] SBD 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311027 insulin isophane, human 100 UNT/ML Injectable Suspension [Novolin N] SBD 82f1445c-b2c6-445a-82cf-ba8825fac776 17 1654862 3 ML insulin isophane, human 100 UNT/ML Pen Injector SCD 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311028 insulin isophane, human 100 UNT/ML Injectable Suspension SCD 82f1445c-b2c6-445a-82cf-ba8825fac776 17 2206099 3 ML Novolin N 100 UNT/ML Pen Injector SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311028 insulin isophane (NPH), human 100 UNT/ML Injectable Suspension SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 1654862 insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 1654862 insulin isophane U-100 per 3 ML Pen Injector SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311027 Novolin N 100 UNT/ML Injectable Suspension SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 2206099 Novolin N 100 UNT/ML per 3 ML Pen Injector SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 311027 ReliOn Novolin N 100 UNT/ML Injectable Suspension SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 2206099 Relion Novolin N 100 UNT/ML per 3 ML Pen Injector SY 82f1445c-b2c6-445a-82cf-ba8825fac776 17 1654862 insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector PSN 69dffec8-6ea9-441b-b795-042dcc26843d 1 2206099 NovoLIN N 100 UNT/mL in 3 mL Pen Injector PSN 69dffec8-6ea9-441b-b795-042dcc26843d 1 2206099 3 ML insulin isophane, human 100 UNT/ML Pen Injector [Novolin N] SBD 69dffec8-6ea9-441b-b795-042dcc26843d 1 1654862 3 ML insulin isophane, human 100 UNT/ML Pen Injector SCD 69dffec8-6ea9-441b-b795-042dcc26843d 1 2206099 3 ML Novolin N 100 UNT/ML Pen Injector SY 69dffec8-6ea9-441b-b795-042dcc26843d 1 1654862 insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector SY 69dffec8-6ea9-441b-b795-042dcc26843d 1 1654862 insulin isophane U-100 per 3 ML Pen Injector SY 69dffec8-6ea9-441b-b795-042dcc26843d 1 2206099 Novolin N 100 UNT/ML per 3 ML Pen Injector SY 69dffec8-6ea9-441b-b795-042dcc26843d 1 2206099 Relion Novolin N 100 UNT/ML per 3 ML Pen Injector SY 69dffec8-6ea9-441b-b795-042dcc26843d 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0169-3004-15 00169300415 5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3004-01) 2019-09-06 0000-00-00 No No Current