Home NDC 0169-3003 Novolin
Product NDC 0169-3003
11-digit product format 001693003
Labeler code 0169
Product ID 0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
Type HUMAN OTC DRUG
Nonproprietary name Human Insulin
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Novo Nordisk
Application BLA019938
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 R
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 311033 Internal RxNorm lookup 311034 Internal RxNorm lookup 2206090 Internal RxNorm lookup 2206092 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 0169-3003-01 NovolinR 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 19 0169-3003-12 NovolinR 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 19 0169-3003-15 NovolinR 5 in 1 CARTON INJECTION, SOLUTION 5 19 0169-3003-25 NovolinR 5 in 1 CARTON INJECTION, SOLUTION 5 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INSULIN HUMAN ACTIVE INGREDIENT 1Y17CTI5SR NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 INSULIN HUMAN ACTIVE MOIETY 1Y17CTI5SR NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 METACRESOL INACTIVE INGREDIENT GGO4Y809LO NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 WATER INACTIVE INGREDIENT 059QF0KO0R NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12 ZINC CHLORIDE INACTIVE INGREDIENT 86Q357L16B NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-3003 NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] 19 Current NDC, Legacy NDC, 4 package rows 20221208_aee7f1f3-612c-4027-8ce9-4fd1f41eed71.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 019938 Novolin R insulin human 351(a) OTC 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2206090 insulin regular, human 100 UNT/1 mL in 3 mL Pen Injector PSN aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206092 NovoLIN R 100 UNT/mL in 3 mL Pen Injector PSN aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311033 NovoLIN R 100 UNT/ML Injectable Solution PSN aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311034 regular insulin, human 100 UNT/ML Injectable Solution PSN aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206092 3 ML insulin, regular, human 100 UNT/ML Pen Injector [Novolin R] SBD aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311033 insulin, regular, human 100 UNT/ML Injectable Solution [Novolin R] SBD aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206090 3 ML insulin, regular, human 100 UNT/ML Pen Injector SCD aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311034 insulin, regular, human 100 UNT/ML Injectable Solution SCD aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206092 3 ML Novolin R 100 UNT/ML Pen Injector SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206090 insulin regular, human 100 UNT/1 ML per 3 ML Pen Injector SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311034 insulin, human regular 100 UNT/ML Injectable Solution SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 311033 Novolin R 100 UNT/ML Injectable Solution SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206092 Novolin R 100 UNT/ML per 3 ML Pen Injector SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19 2206092 Relion Novolin R 100 UNT/ML per 3 ML Pen Injector SY aee7f1f3-612c-4027-8ce9-4fd1f41eed71 19
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0169-3003-01 00169300301 3 mL in 1 SYRINGE, PLASTIC 3 ml Historical 0169-3003-12 00169300312 3 mL in 1 SYRINGE, PLASTIC 3 ml Historical 0169-3003-15 00169300315 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01) 2019-09-06 0000-00-00 No No Current 0169-3003-25 00169300325 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12) 2019-09-06 0000-00-00 No No Current