Home NDC 0169-6338 NOVOLOG
Product NDC 0169-6338
11-digit product format 001696338
Labeler code 0169
Product ID 0169-6338_de82c22d-ea25-44ef-8bcd-c3cda9e84e59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name insulin aspart
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Novo Nordisk
Application BLA020986
Marketing category BLA
Marketing start 2013-10-31
Substance INSULIN ASPART
Active strength 100 [iU]/mL
Pharmacologic classes Insulin Analog [EPC], Insulin [CS]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 0169-6338 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0169-6338 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base NOVOLOG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INSULIN ASPART 100 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D933668QVX Internal UNII lookup 059QF0KO0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311040 Internal RxNorm lookup 351926 Internal RxNorm lookup 1653196 Internal RxNorm lookup 1653198 Internal RxNorm lookup 1653202 Internal RxNorm lookup 1653204 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 0169-6338-10 NOVOLOG 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 34 0169-6338-10 NOVOLOG 5 in 1 CARTON INJECTION, SOLUTION 5 34 0169-6338-90 NOVOLOG 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 34 0169-6338-97 NOVOLOG 1 in 1 CARTON INJECTION, SOLUTION 1 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INSULIN ASPART ACTIVE INGREDIENT D933668QVX NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 INSULIN ASPART ACTIVE MOIETY D933668QVX NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 METACRESOL INACTIVE INGREDIENT GGO4Y809LO NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 PHENOL INACTIVE INGREDIENT 339NCG44TV NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19 ZINC INACTIVE INGREDIENT J41CSQ7QDS NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK] 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-6338 NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION) INJECTION, SOLUTION [NOVO NORDISK] 34 Current NDC, Legacy NDC, 4 package rows 20250122_3a1e73a2-3009-40d0-876c-b4cb2be56fc5.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 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Insulin Aspart INSULIN ASPART REMEDYREPACK INC. b3d77cb0-cd47-441f-8f54-5329c655da9c 2026-01-14 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Aspart INSULIN ASPART A-S Medication Solutions c3e4c46e-5211-4f05-b7ab-1e9ad270876b 2024-09-11 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Aspart INSULIN ASPART A-S Medication Solutions bfd2b192-35e5-4773-ab73-802565b2ad78 2024-03-14 Warnings, Adverse reactions Exact identifier application number: BLA020986 NOVOLOG INSULIN ASPART A-S Medication Solutions 13891e5a-e57a-46e8-911c-2f680352b52b 2023-12-15 Warnings, Adverse reactions Exact identifier application number: BLA020986 NOVOLOG INSULIN ASPART A-S Medication Solutions e172b4f8-9b25-4019-8e09-afc10b2f30c9 2023-12-09 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Aspart INSULIN ASPART Novo Nordisk Pharma, Inc. bee5b358-c863-420b-be73-ced2e920c499 2023-02-28 Warnings, Adverse reactions Exact identifier application number: BLA020986 Insulin Diluting Medium for NovoLog WATER INJECTION Novo Nordisk 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 2023-02-28 Warnings, Adverse reactions Exact identifier application number: BLA020986 ndc (product): 0169-6338
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020986 Novolog insulin aspart 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1653196 insulin aspart 100 UNT/ML in 3 ML Cartridge PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653202 insulin aspart 100 UNT/ML in 3 ML Pen Injector PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 311040 insulin aspart 100 UNT/ML Injectable Solution PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653198 NovoLOG 100 UNT/ML in 3 ML Cartridge PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653204 NovoLOG 100 UNT/ML in 3 ML Pen Injector PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 351926 NovoLOG 100 UNT/ML Injectable Solution PSN 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653198 3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog] SBD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653204 3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog] SBD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 351926 insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog] SBD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653196 3 ML insulin aspart, human 100 UNT/ML Cartridge SCD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653202 3 ML insulin aspart, human 100 UNT/ML Pen Injector SCD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 311040 insulin aspart, human 100 UNT/ML Injectable Solution SCD 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653198 3 ML NovoLog 100 UNT/ML Cartridge SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653204 3 ML NovoLog 100 UNT/ML Pen Injector SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 311040 insulin analog, aspart 100 UNT/ML Injectable Solution SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653196 insulin, aspart, human 100 UNT/ML per 3 ML Cartridge SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653202 insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 351926 NovoLog 100 UNT/ML Injectable Solution SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653204 NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34 1653204 NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector SY 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 34
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 0169-6338-10 00169633810 3 mL in 1 SYRINGE, PLASTIC 3 ml Historical 0169-6338-90 00169633890 3 mL in 1 SYRINGE, PLASTIC 3 ml Historical 0169-6338-97 00169633897 1 in 1 CARTON Historical