FDA.reportPublic FDA data

NOVOLOG

Product NDC
50090-4500
11-digit product format
500904500
Labeler code
50090
Product ID
50090-4500_5907ee0c-c7d5-4e1c-9c12-8390ccb34c42
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
NOVOLOG
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1653202Internal RxNorm lookup
1653204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13891e5a-e57a-46e8-911c-2f680352b52bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4500-0NOVOLOG3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION36
50090-4500-0NOVOLOG5 in 1 CARTONINJECTION, SOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4500-0ML - Milliliter50090-4500e14c0240-61a1-4933-b552-d91bb560a4dc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4500NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231216_13891e5a-e57a-46e8-911c-2f680352b52b.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
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
ndc (product): 50090-4500
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)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653202insulin aspart 100 UNT/ML in 3 ML Pen InjectorPSN13891e5a-e57a-46e8-911c-2f680352b52b6
1653204NovoLOG 100 UNT/ML in 3 ML Pen InjectorPSN13891e5a-e57a-46e8-911c-2f680352b52b6
16532043 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]SBD13891e5a-e57a-46e8-911c-2f680352b52b6
16532023 ML insulin aspart, human 100 UNT/ML Pen InjectorSCD13891e5a-e57a-46e8-911c-2f680352b52b6
16532043 ML NovoLog 100 UNT/ML Pen InjectorSY13891e5a-e57a-46e8-911c-2f680352b52b6
1653202insulin, aspart, human 100 UNT/ML per 3 ML Pen InjectorSY13891e5a-e57a-46e8-911c-2f680352b52b6
1653204NovoLog FlexPen 100 UNT/ML per 3 ML Pen InjectorSY13891e5a-e57a-46e8-911c-2f680352b52b6
1653204NovoLog FlexTouch 100 UNT/ML per 3 ML Pen InjectorSY13891e5a-e57a-46e8-911c-2f680352b52b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4500-0500904500005 SYRINGE, PLASTIC in 1 CARTON (50090-4500-0) / 3 mL in 1 SYRINGE, PLASTIC2019-09-040000-00-00NoNoCurrent