FDA.reportPublic FDA data

.Insulin Aspart Protamine and Insulin Aspart

Product NDC
50090-4959
11-digit product format
500904959
Labeler code
50090
Product ID
50090-4959_6831854d-54bc-417d-8ddc-1cb93c534dda
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
.Insulin Aspart Protamine and Insulin Aspart
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D933668QVXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847191Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
14499781-b90e-47d5-a7de-006965439b94Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4959-02023-02-07C16284748780-1f386c64a-435d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 safely and effectively. See full prescribing information for INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30. INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 injectable suspension, for subcutaneous use Initial U.S. Approval: 2001 This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart).
50090-4959-02023-01-30C16284748780-1f386c64a-435d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 safely and effectively. See full prescribing information for INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30. INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 injectable suspension, for subcutaneous use Initial U.S. Approval: 2001 This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4959-0.Insulin Aspart Protamine and Insulin Aspart5 in 1 CARTONINJECTION, SUSPENSION510
50090-4959-0.Insulin Aspart Protamine and Insulin Aspart3 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4959-0ML - Milliliter50090-49597e2de542-073d-4d46-895a-f10da3146ede12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4959.INSULIN ASPART PROTAMINE AND INSULIN ASPART (INSULIN ASPART) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240224_14499781-b90e-47d5-a7de-006965439b94.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
ndc (product): 50090-4959
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)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN14499781-b90e-47d5-a7de-006965439b9410
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD14499781-b90e-47d5-a7de-006965439b9410
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY14499781-b90e-47d5-a7de-006965439b9410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4959-0500904959005 SYRINGE, PLASTIC in 1 CARTON (50090-4959-0) / 3 mL in 1 SYRINGE, PLASTIC2020-03-120000-00-00NoNoCurrent