FDA.reportPublic FDA data

NOVOLOG MIX 70/30

Product NDC
50090-4085
11-digit product format
500904085
Labeler code
50090
Product ID
50090-4085_1b336ad4-9d0f-4d6e-bfff-94cf9545f193
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA021172
Marketing category
BLA
Marketing start
2002-09-11
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NOVOLOG MIX 70/30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui847191, 977840

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4085-02023-02-07C16284748780-1f386c649-b9d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NOVOLOG MIX 70/30 safely and effectively. See full prescribing information for NOVOLOG MIX 70/30. NOVOLOG ® MIX 70/30 (insulin aspart protamine and insulin aspart) injectable suspension, for subcutaneous use Initial U.S. Approval: 2001
50090-4085-02023-01-30C16284748780-1f386c649-b9d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NOVOLOG MIX 70/30 safely and effectively. See full prescribing information for NOVOLOG MIX 70/30. NOVOLOG ® MIX 70/30 (insulin aspart protamine and insulin aspart) injectable suspension, for subcutaneous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4085-0NOVOLOG MIX 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION36
50090-4085-0NOVOLOG MIX 70/305 in 1 CARTONINJECTION, SUSPENSION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4085-0ML - Milliliter50090-4085be1f19fc-0c2f-4094-8178-59da414b12a212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4085NOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240125_ead74453-dd15-4836-8ad6-5b14ac168d02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSNead74453-dd15-4836-8ad6-5b14ac168d026
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSNead74453-dd15-4836-8ad6-5b14ac168d026
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBDead74453-dd15-4836-8ad6-5b14ac168d026
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCDead74453-dd15-4836-8ad6-5b14ac168d026
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSYead74453-dd15-4836-8ad6-5b14ac168d026
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSYead74453-dd15-4836-8ad6-5b14ac168d026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4085-0500904085005 SYRINGE, PLASTIC in 1 CARTON (50090-4085-0) / 3 mL in 1 SYRINGE, PLASTIC2019-01-250000-00-00NoNoCurrent