FDA.reportPublic FDA data

Insulin Aspart

Product NDC
50090-4956
11-digit product format
500904956
Labeler code
50090
Product ID
50090-4956_ebe16d72-f034-4b0c-a663-f8bcdb2e7936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA020986
Marketing category
BLA
Marketing start
2003-01-22
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
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
1653202Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3e4c46e-5211-4f05-b7ab-1e9ad270876bAvailable on FDA.report

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
50090-4956-02023-02-06C16284748780-1f386c64a-2ad1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART safely and effectively. See full prescribing information for INSULIN ASPART. INSULIN ASPART injection, for subcutaneous or intravenous use Initial U.S. Approval: 2000 This product is NovoLog (insulin aspart).
50090-4956-02023-01-30C16284748780-1f386c64a-2ad1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART safely and effectively. See full prescribing information for INSULIN ASPART. INSULIN ASPART injection, for subcutaneous or intravenous use Initial U.S. Approval: 2000 This product is NovoLog (insulin aspart).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4956-0Insulin Aspart3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION39
50090-4956-0Insulin Aspart5 in 1 CARTONINJECTION, SOLUTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4956-0ML - Milliliter50090-49568a12a454-7aa9-422b-9318-f742567da92012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4956INSULIN ASPART INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240912_c3e4c46e-5211-4f05-b7ab-1e9ad270876b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin AspartINSULIN ASPARTREMEDYREPACK INC.b3d77cb0-cd47-441f-8f54-5329c655da9c2026-01-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTA-S Medication Solutionsc3e4c46e-5211-4f05-b7ab-1e9ad270876b2024-09-11Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 50090-4956
Insulin AspartINSULIN ASPARTA-S Medication Solutionsbfd2b192-35e5-4773-ab73-802565b2ad782024-03-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
NOVOLOGINSULIN ASPARTA-S Medication Solutions13891e5a-e57a-46e8-911c-2f680352b52b2023-12-15Warnings, Adverse reactionsExact identifier
application number: BLA020986
NOVOLOGINSULIN ASPARTA-S Medication Solutionse172b4f8-9b25-4019-8e09-afc10b2f30c92023-12-09Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTNovo Nordisk Pharma, Inc.bee5b358-c863-420b-be73-ced2e920c4992023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020986Novologinsulin aspart351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653202insulin aspart 100 UNT/ML in 3 ML Pen InjectorPSNc3e4c46e-5211-4f05-b7ab-1e9ad270876b9
16532023 ML insulin aspart, human 100 UNT/ML Pen InjectorSCDc3e4c46e-5211-4f05-b7ab-1e9ad270876b9
1653202insulin, aspart, human 100 UNT/ML per 3 ML Pen InjectorSYc3e4c46e-5211-4f05-b7ab-1e9ad270876b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4956-0500904956005 SYRINGE, PLASTIC in 1 CARTON (50090-4956-0) / 3 mL in 1 SYRINGE, PLASTIC2020-03-060000-00-00NoNoCurrent