FDA.reportPublic FDA data

Insulin Aspart

Product NDC
70518-3865
Requested package NDC
70518-3865-0
11-digit product format
705183865
Labeler code
70518
Product ID
70518-3865_485a3f8d-de3a-d94f-e063-6294a90ac25f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
BLA020986
Marketing category
BLA
Marketing start
2023-09-18
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Insulin Aspart
Listing expiration
2027-12-31

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
b3d77cb0-cd47-441f-8f54-5329c655da9cAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3865-0Insulin Aspart5 in 1 CARTONINJECTION, SOLUTION55
70518-3865-0Insulin Aspart3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3865INSULIN ASPART INJECTION, SOLUTION [REMEDYREPACK INC.]2Current NDC, 2 package rows20240403_b3d77cb0-cd47-441f-8f54-5329c655da9c.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
ndc (package): 70518-3865-0
ndc (product): 70518-3865
ndc11 (package): 70518386500
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
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)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653202insulin aspart 100 UNT/ML in 3 ML Pen InjectorPSNb3d77cb0-cd47-441f-8f54-5329c655da9c5
16532023 ML insulin aspart, human 100 UNT/ML Pen InjectorSCDb3d77cb0-cd47-441f-8f54-5329c655da9c5
1653202insulin, aspart, human 100 UNT/ML per 3 ML Pen InjectorSYb3d77cb0-cd47-441f-8f54-5329c655da9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3865-0705183865005 SYRINGE, PLASTIC in 1 CARTON (70518-3865-0) / 3 mL in 1 SYRINGE, PLASTIC2023-09-18NoNoCurrent