FDA.reportPublic FDA data

Insulin Aspart Protamine and Insulin Aspart

Product NDC
70518-3236
Requested package NDC
70518-3236-0
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

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 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 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
847191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5d9f0e10-edb9-4960-bd62-cf406e75bbe7Available 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
70518-3236-0Insulin 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

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NovoLog Mix 70/30INSULIN ASPARTREMEDYREPACK INC.66da64f7-ca50-47d2-95fa-de37005eef852026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA021172
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTREMEDYREPACK INC.5d9f0e10-edb9-4960-bd62-cf406e75bbe72026-04-07Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (package): 70518-3236-0
ndc (product): 70518-3236
ndc11 (package): 70518323600
NovoLog Mix 70/30INSULIN ASPARTA-S Medication Solutions19888a44-b330-462a-864d-338c5893dd632026-01-29Warnings, Adverse reactionsExact identifier
application number: BLA021172
.Insulin Aspart Protamine and Insulin AspartINSULIN ASPARTA-S Medication Solutions14499781-b90e-47d5-a7de-006965439b942024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA021172
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTNovo Nordisk Pharma, Inc.fc94baa4-3606-48bc-a781-9617ab6960ef2023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA021172
NovoLog Mix 70/30INSULIN ASPARTNovo Nordisk1861fcee-7673-4afe-a206-08fa05c0add22023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA021172

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021172Novolog Mix 70/30insulin aspart protamine and insulin aspart351(a)Rx2026-09-01

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