FDA.reportPublic FDA data

Novolin

Product NDC
0169-3004
11-digit product format
001693004
Labeler code
0169
Product ID
0169-3004_652d3fd6-809f-476e-9159-a1beffb9ea01
Type
HUMAN OTC DRUG
Nonproprietary name
Human Insulin
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
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
Rxcui311027, 311028, 1654862, 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
0169-3004-01NovolinN3 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION317
0169-3004-12NovolinN3 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION317
0169-3004-15NovolinN5 in 1 CARTONINJECTION, SUSPENSION517
0169-3004-25NovolinN5 in 1 CARTONINJECTION, SUSPENSION517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3004-01ML - Milliliter0169-300437a2299e-ae22-4b8d-9fe8-451b15802c4912022-06-06
0169-3004-12ML - Milliliter0169-30048e7d74d5-8f95-434d-8824-54128cbfd30312022-06-06
0169-3004-15ML - Milliliter0169-30045c744438-8aa3-4edf-9f2e-1f4607bcd74c12020-01-03
0169-3004-25ML - Milliliter0169-300465cf0552-75bb-450b-a1f3-471040aeba1512020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3004NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]17Current NDC, Legacy NDC, 4 package rows20221208_82f1445c-b2c6-445a-82cf-ba8825fac776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654862insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen InjectorPSN82f1445c-b2c6-445a-82cf-ba8825fac77617
311028insulin isophane (NPH), human 100 UNT/mL Injectable SuspensionPSN82f1445c-b2c6-445a-82cf-ba8825fac77617
2206099NovoLIN N 100 UNT/mL in 3 mL Pen InjectorPSN82f1445c-b2c6-445a-82cf-ba8825fac77617
311027NovoLIN N 100 UNT/ML Injectable SuspensionPSN82f1445c-b2c6-445a-82cf-ba8825fac77617
22060993 ML insulin isophane, human 100 UNT/ML Pen Injector [Novolin N]SBD82f1445c-b2c6-445a-82cf-ba8825fac77617
311027insulin isophane, human 100 UNT/ML Injectable Suspension [Novolin N]SBD82f1445c-b2c6-445a-82cf-ba8825fac77617
16548623 ML insulin isophane, human 100 UNT/ML Pen InjectorSCD82f1445c-b2c6-445a-82cf-ba8825fac77617
311028insulin isophane, human 100 UNT/ML Injectable SuspensionSCD82f1445c-b2c6-445a-82cf-ba8825fac77617
22060993 ML Novolin N 100 UNT/ML Pen InjectorSY82f1445c-b2c6-445a-82cf-ba8825fac77617
311028insulin isophane (NPH), human 100 UNT/ML Injectable SuspensionSY82f1445c-b2c6-445a-82cf-ba8825fac77617
1654862insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen InjectorSY82f1445c-b2c6-445a-82cf-ba8825fac77617
1654862insulin isophane U-100 per 3 ML Pen InjectorSY82f1445c-b2c6-445a-82cf-ba8825fac77617
311027Novolin N 100 UNT/ML Injectable SuspensionSY82f1445c-b2c6-445a-82cf-ba8825fac77617
2206099Novolin N 100 UNT/ML per 3 ML Pen InjectorSY82f1445c-b2c6-445a-82cf-ba8825fac77617
311027ReliOn Novolin N 100 UNT/ML Injectable SuspensionSY82f1445c-b2c6-445a-82cf-ba8825fac77617
2206099Relion Novolin N 100 UNT/ML per 3 ML Pen InjectorSY82f1445c-b2c6-445a-82cf-ba8825fac77617
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-3004-01001693004013 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-3004-12001693004123 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-3004-15001693004155 SYRINGE, PLASTIC in 1 CARTON (0169-3004-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3004-01) 2019-09-060000-00-00NoNoCurrent
0169-3004-25001693004255 SYRINGE, PLASTIC in 1 CARTON (0169-3004-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3004-12) 2019-09-060000-00-00NoNoCurrent