Insulin Aspart

Product NDC
70518-3865
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

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 Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui1653202

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

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, PLASTIC2023-09-18NoNoHistorical