FDA.reportPublic FDA data

NovoLog Mix 70/30

Product NDC
50090-4085
11-digit product format
500904085
Labeler code
50090
Product ID
50090-4085_a15ae450-ec81-47e4-803f-25b511223261
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
Marketing end
0000-00-00
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS],Insulin Analog [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 productproduct50090-4085DDiscontinued by firm2026-09-14
excluded packagepackage50090-408550090-4085-0DDiscontinued 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
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]6Legacy NDC, 2 package rows20240125_ead74453-dd15-4836-8ad6-5b14ac168d02.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NovoLog Mix 70/30INSULIN ASPARTREMEDYREPACK INC.66da64f7-ca50-47d2-95fa-de37005eef852026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA021172
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTREMEDYREPACK INC.5d9f0e10-edb9-4960-bd62-cf406e75bbe72026-04-07Warnings, Adverse reactionsExact identifier
application number: BLA021172
NovoLog Mix 70/30INSULIN ASPARTA-S Medication Solutions19888a44-b330-462a-864d-338c5893dd632026-01-29Warnings, Adverse reactionsExact identifier
application number: BLA021172
.Insulin Aspart Protamine and Insulin AspartINSULIN ASPARTA-S Medication Solutions14499781-b90e-47d5-a7de-006965439b942024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA021172
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTNovo Nordisk Pharma, Inc.fc94baa4-3606-48bc-a781-9617ab6960ef2023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA021172
NovoLog Mix 70/30INSULIN ASPARTNovo Nordisk1861fcee-7673-4afe-a206-08fa05c0add22023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA021172

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021172Novolog Mix 70/30insulin aspart protamine and insulin aspart351(a)Rx2026-08-01

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