FDA.reportPublic FDA data

NovoLog Mix 70/30

Product NDC
70518-2119
11-digit product format
705182119
Labeler code
70518
Product ID
70518-2119_521a565a-0a44-0a60-e063-6394a90abf13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
BLA021172
Marketing category
BLA
Marketing start
2019-05-28
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2119-0d630ba8d3edf…732f749b63fb…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2119-0557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
847191Internal RxNorm lookup
977840Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66da64f7-ca50-47d2-95fa-de37005eef85Available 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
70518-2119-0NovoLog Mix 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION314
70518-2119-0NovoLog Mix 70/305 in 1 CARTONINJECTION, SUSPENSION514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2119NOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250308_66da64f7-ca50-47d2-95fa-de37005eef85.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
ndc (product): 70518-2119
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTREMEDYREPACK INC.5d9f0e10-edb9-4960-bd62-cf406e75bbe72026-04-07Warnings, Adverse reactionsExact identifier
application number: BLA021172
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)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN66da64f7-ca50-47d2-95fa-de37005eef8514
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSN66da64f7-ca50-47d2-95fa-de37005eef8514
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBD66da64f7-ca50-47d2-95fa-de37005eef8514
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD66da64f7-ca50-47d2-95fa-de37005eef8514
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY66da64f7-ca50-47d2-95fa-de37005eef8514
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSY66da64f7-ca50-47d2-95fa-de37005eef8514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2119-0705182119005 SYRINGE, PLASTIC in 1 CARTON (70518-2119-0) / 3 mL in 1 SYRINGE, PLASTIC2019-05-280000-00-00NoNoCurrent