FDA.reportPublic FDA data

Novolin

Product NDC
50090-6565
11-digit product format
500906565
Labeler code
50090
Product ID
50090-6565_4686ca34-20ab-40c8-89ca-c291d85b595d
Type
HUMAN OTC DRUG
Nonproprietary name
Human Insulin
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-6565DDiscontinued by firm2026-09-14
excluded packagepackage50090-656550090-6565-0DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6565-0NovolinN5 in 1 CARTONINJECTION, SUSPENSION51
50090-6565-0NovolinN3 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6565-0ML - Milliliter50090-6565b192e28a-c0e1-40be-8de1-e456099a7b9b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6565NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230722_69dffec8-6ea9-441b-b795-042dcc26843d.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novolin NHUMAN INSULINNovo Nordisk82f1445c-b2c6-445a-82cf-ba8825fac7762022-11-23Warnings, Adverse reactionsExact identifier
application number: BLA019959

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019959Novolin Ninsulin isophane human351(a)OTC2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654862insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen InjectorPSN69dffec8-6ea9-441b-b795-042dcc26843d1
2206099NovoLIN N 100 UNT/mL in 3 mL Pen InjectorPSN69dffec8-6ea9-441b-b795-042dcc26843d1
22060993 ML insulin isophane, human 100 UNT/ML Pen Injector [Novolin N]SBD69dffec8-6ea9-441b-b795-042dcc26843d1
16548623 ML insulin isophane, human 100 UNT/ML Pen InjectorSCD69dffec8-6ea9-441b-b795-042dcc26843d1
22060993 ML Novolin N 100 UNT/ML Pen InjectorSY69dffec8-6ea9-441b-b795-042dcc26843d1
1654862insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen InjectorSY69dffec8-6ea9-441b-b795-042dcc26843d1
1654862insulin isophane U-100 per 3 ML Pen InjectorSY69dffec8-6ea9-441b-b795-042dcc26843d1
2206099Novolin N 100 UNT/ML per 3 ML Pen InjectorSY69dffec8-6ea9-441b-b795-042dcc26843d1
2206099Relion Novolin N 100 UNT/ML per 3 ML Pen InjectorSY69dffec8-6ea9-441b-b795-042dcc26843d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6565-0500906565005 SYRINGE, PLASTIC in 1 CARTON (50090-6565-0) / 3 mL in 1 SYRINGE, PLASTIC2023-07-18NoNoHistorical