FDA.reportPublic FDA data

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

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
IngredientStrength
INSULIN HUMAN100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui213442, 311048

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0403-02023-08-01C16284748780-19d75b9d0-8ccb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NOVOLIN 70/30 safely and effectively. See full prescribing information for NOVOLIN 70/30. NOVOLIN ® 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use Initial U.S. Approval: 1991
50090-0403-02020-01-31C16284748780-19d75b9d0-8ccb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NOVOLIN 70/30 safely and effectively. See full prescribing information for NOVOLIN 70/30. NOVOLIN ® 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0403-0Novolin70/3010 mL in 1 VIALINJECTION, SUSPENSION1014
50090-0403-0Novolin70/301 in 1 CARTONINJECTION, SUSPENSION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0403-0ML - Milliliter50090-04032891ecaa-783b-4d88-8deb-63e4ab2595d012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0403NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20230801_e825d7e9-467c-4f50-a6d6-f2602449c1de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSNe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442NovoLIN 70/30 Injectable SuspensionPSNe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]SBDe825d7e9-467c-4f50-a6d6-f2602449c1de14
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCDe825d7e9-467c-4f50-a6d6-f2602449c1de14
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442Novolin 70/30 Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442Relion Novolin 70/30 Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0403-0500900403001 VIAL in 1 CARTON (50090-0403-0) / 10 mL in 1 VIAL1 vial2014-11-28NoNoHistorical