FDA.reportPublic FDA data

Insulin Aspart

Product NDC
50090-4955
11-digit product format
500904955
Labeler code
50090
Product ID
50090-4955_25a18afd-98d0-4529-aae0-ad545fa984b8
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
2001-08-27
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 Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui311040

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
50090-4955-02023-02-07C16284748780-1f386c649-bcab-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).
50090-4955-02023-01-30C16284748780-1f386c649-bcab-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
50090-4955-0Insulin Aspart10 mL in 1 VIAL, GLASSINJECTION, SOLUTION108
50090-4955-0Insulin Aspart1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4955INSULIN ASPART INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240316_bfd2b192-35e5-4773-ab73-802565b2ad78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311040insulin aspart 100 UNT/ML Injectable SolutionPSNbfd2b192-35e5-4773-ab73-802565b2ad788
311040insulin aspart, human 100 UNT/ML Injectable SolutionSCDbfd2b192-35e5-4773-ab73-802565b2ad788
311040insulin analog, aspart 100 UNT/ML Injectable SolutionSYbfd2b192-35e5-4773-ab73-802565b2ad788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4955-0500904955001 VIAL, GLASS in 1 CARTON (50090-4955-0) / 10 mL in 1 VIAL, GLASS2020-03-060000-00-00NoNoCurrent