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

Additional Listing Data#

Finished product
Yes
Brand name base
Novolin
Brand name suffix
N
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui1654862, 2206099

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

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