Home NDC 50090-0403 Novolin
Product NDC 50090-0403
11-digit product format 500900403
Labeler code 50090
Product ID 50090-0403_6ffa1a5f-1a62-4017-999c-8ef13fa4f0c7
Type HUMAN OTC DRUG
Nonproprietary name Human Insulin
Dosage form INJECTION, SUSPENSION
Route SUBCUTANEOUS
Labeler A-S Medication Solutions
Application BLA019991
Marketing category BLA
Marketing start 1991-06-25
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50090-0403-0 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50090-0403-0 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50090-0403-0 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50090-0403-0 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50090-0403-0 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50090-0403-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-0403-0 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Novolin
Brand name suffix 70/30
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213442 Internal RxNorm lookup 311048 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0403-0 Novolin70/30 10 mL in 1 VIAL INJECTION, SUSPENSION 10 14 50090-0403-0 Novolin70/30 1 in 1 CARTON INJECTION, SUSPENSION 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0403 NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] 14 Current NDC, Legacy NDC, 2 package rows 20230801_e825d7e9-467c-4f50-a6d6-f2602449c1de.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 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019991 Novolin 70/30 insulin isophane human and insulin human 351(a) OTC 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 311048 insulin, human isophane / insulin regular 70/30 Injectable Suspension PSN e825d7e9-467c-4f50-a6d6-f2602449c1de 14 213442 NovoLIN 70/30 Injectable Suspension PSN e825d7e9-467c-4f50-a6d6-f2602449c1de 14 213442 insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin] SBD e825d7e9-467c-4f50-a6d6-f2602449c1de 14 311048 insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension SCD e825d7e9-467c-4f50-a6d6-f2602449c1de 14 311048 insulin, human mixed 70/30 100 UNT/ML Injectable Suspension SY e825d7e9-467c-4f50-a6d6-f2602449c1de 14 213442 Novolin 70/30 Injectable Suspension SY e825d7e9-467c-4f50-a6d6-f2602449c1de 14 213442 Relion Novolin 70/30 Injectable Suspension SY e825d7e9-467c-4f50-a6d6-f2602449c1de 14
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-0403-0 50090040300 1 VIAL in 1 CARTON (50090-0403-0) / 10 mL in 1 VIAL 1 vial 2014-11-28 No No Current