FDA.reportPublic FDA data

NovoLog Mix 70/30

Product NDC
0169-3696
Requested package NDC
0169-3696-98
11-digit product format
001693696
Labeler code
0169
Product ID
0169-3696_ecfd53fb-5887-48df-bc66-c32f8ff0cf67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA021172
Marketing category
BLA
Marketing start
2002-09-11
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0169-36960169-3696-98DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
NovoLog Mix 70/30
Listing expiration
2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351297Internal RxNorm lookup
847191Internal RxNorm lookup
977840Internal RxNorm lookup
977842Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1861fcee-7673-4afe-a206-08fa05c0add2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3696-19NovoLog Mix 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION324
0169-3696-19NovoLog Mix 70/305 in 1 CARTONINJECTION, SUSPENSION524
0169-3696-90NovoLog Mix 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION324
0169-3696-97NovoLog Mix 70/301 in 1 CARTONINJECTION, SUSPENSION124
0169-3696-97NovoLog Mix 70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION324
0169-3696-98NovoLog Mix 70/301 in 1 CARTONINJECTION, SUSPENSION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3696-19ML - Milliliter0169-3696a4605715-f412-41e5-9897-aa21e6eb9fff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN ASPARTACTIVE INGREDIENTD933668QVXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
insulin aspartACTIVE MOIETYD933668QVXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
ZINCINACTIVE INGREDIENTJ41CSQ7QDSNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]16
INSULIN ASPARTACTIVE INGREDIENTD933668QVXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
INSULIN ASPARTACTIVE MOIETYD933668QVXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ANOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ZINCINACTIVE INGREDIENTJ41CSQ7QDSNOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3696NOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]24Current NDC, Legacy NDC, 6 package rows20230315_1861fcee-7673-4afe-a206-08fa05c0add2.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
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
ndc (package): 0169-3696-98
ndc (product): 0169-3696
ndc11 (package): 00169369698

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 InjectorPSN19888a44-b330-462a-864d-338c5893dd6332
351297insulin aspart protamine / insulin aspart 70/30 Injectable SuspensionPSN19888a44-b330-462a-864d-338c5893dd6332
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSN19888a44-b330-462a-864d-338c5893dd6332
977842NovoLOG Mix 70/30 Injectable SuspensionPSN19888a44-b330-462a-864d-338c5893dd6332
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBD19888a44-b330-462a-864d-338c5893dd6332
977842insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable Suspension [NovoLog Mix]SBD19888a44-b330-462a-864d-338c5893dd6332
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD19888a44-b330-462a-864d-338c5893dd6332
351297insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable SuspensionSCD19888a44-b330-462a-864d-338c5893dd6332
351297insulin analog, aspart mixed 70/30 100 UNT/ML Injectable SuspensionSY19888a44-b330-462a-864d-338c5893dd6332
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY19888a44-b330-462a-864d-338c5893dd6332
977842NovoLog Mix 70/30 Injectable SuspensionSY19888a44-b330-462a-864d-338c5893dd6332
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSY19888a44-b330-462a-864d-338c5893dd6332
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN1861fcee-7673-4afe-a206-08fa05c0add224
351297insulin aspart protamine / insulin aspart 70/30 Injectable SuspensionPSN1861fcee-7673-4afe-a206-08fa05c0add224
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSN1861fcee-7673-4afe-a206-08fa05c0add224
977842NovoLOG Mix 70/30 Injectable SuspensionPSN1861fcee-7673-4afe-a206-08fa05c0add224
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBD1861fcee-7673-4afe-a206-08fa05c0add224
977842insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable Suspension [NovoLog Mix]SBD1861fcee-7673-4afe-a206-08fa05c0add224
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD1861fcee-7673-4afe-a206-08fa05c0add224
351297insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable SuspensionSCD1861fcee-7673-4afe-a206-08fa05c0add224
351297insulin analog, aspart mixed 70/30 100 UNT/ML Injectable SuspensionSY1861fcee-7673-4afe-a206-08fa05c0add224
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY1861fcee-7673-4afe-a206-08fa05c0add224
977842NovoLog Mix 70/30 Injectable SuspensionSY1861fcee-7673-4afe-a206-08fa05c0add224
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSY1861fcee-7673-4afe-a206-08fa05c0add224
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
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSNead74453-dd15-4836-8ad6-5b14ac168d026
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSNead74453-dd15-4836-8ad6-5b14ac168d026
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBDead74453-dd15-4836-8ad6-5b14ac168d026
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCDead74453-dd15-4836-8ad6-5b14ac168d026
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSYead74453-dd15-4836-8ad6-5b14ac168d026
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSYead74453-dd15-4836-8ad6-5b14ac168d026
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN973a9333-fec7-46dd-8eb5-25738f06ee542
351297insulin aspart protamine / insulin aspart 70/30 Injectable SuspensionPSN973a9333-fec7-46dd-8eb5-25738f06ee542
977840NovoLOG Mix 70/30 in 3 ML Pen InjectorPSN973a9333-fec7-46dd-8eb5-25738f06ee542
977842NovoLOG Mix 70/30 Injectable SuspensionPSN973a9333-fec7-46dd-8eb5-25738f06ee542
9778403 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen Injector [NovoLog Mix]SBD973a9333-fec7-46dd-8eb5-25738f06ee542
977842insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable Suspension [NovoLog Mix]SBD973a9333-fec7-46dd-8eb5-25738f06ee542
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD973a9333-fec7-46dd-8eb5-25738f06ee542
351297insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Injectable SuspensionSCD973a9333-fec7-46dd-8eb5-25738f06ee542
351297insulin analog, aspart mixed 70/30 100 UNT/ML Injectable SuspensionSY973a9333-fec7-46dd-8eb5-25738f06ee542
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY973a9333-fec7-46dd-8eb5-25738f06ee542
977842NovoLog Mix 70/30 Injectable SuspensionSY973a9333-fec7-46dd-8eb5-25738f06ee542
977840NovoLog Mix 70/30 per 3 ML Pen InjectorSY973a9333-fec7-46dd-8eb5-25738f06ee542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0169-3696-98001693696981 SYRINGE, PLASTIC in 1 CARTON (0169-3696-98) > 3 mL in 1 SYRINGE, PLASTIC (0169-3696-90) 2002-09-110000-00-00NoNoCurrent