FDA.reportPublic FDA data

Insulin Aspart Protamine and Insulin Aspart

Product NDC
70518-3236
11-digit product format
705183236
Labeler code
70518
Product ID
70518-3236_4ede5cbd-51cc-3e1c-e063-6294a90a8198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
BLA021172
Marketing category
BLA
Marketing start
2022-01-28
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 Protamine and Insulin Aspart
Brand name suffix
Mix 70/30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui847191

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
70518-3236-0Insulin Aspart Protamine and Insulin AspartMix 70/305 in 1 CARTONINJECTION, SUSPENSION59
70518-3236-0Insulin Aspart Protamine and Insulin AspartMix 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3236INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250502_5d9f0e10-edb9-4960-bd62-cf406e75bbe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN5d9f0e10-edb9-4960-bd62-cf406e75bbe79
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD5d9f0e10-edb9-4960-bd62-cf406e75bbe79
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY5d9f0e10-edb9-4960-bd62-cf406e75bbe79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3236-0705183236005 SYRINGE, PLASTIC in 1 CARTON (70518-3236-0) / 3 mL in 1 SYRINGE, PLASTIC2022-01-280000-00-00NoNoCurrent