FDA.reportPublic FDA data

NovoLog Mix 70/30

Product NDC
0169-3685
11-digit product format
001693685
Labeler code
0169
Product ID
0169-3685_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
2001-11-01
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

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 Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui351297, 847191, 977840, 977842

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
0169-3685-12NovoLog Mix 70/301 in 1 CARTONINJECTION, SUSPENSION124
0169-3685-12NovoLog Mix 70/3010 mL in 1 VIAL, GLASSINJECTION, SUSPENSION1024
0169-3685-92NovoLog Mix 70/301 in 1 CARTONINJECTION, SUSPENSION124
0169-3685-92NovoLog Mix 70/3010 mL in 1 VIAL, GLASSINJECTION, SUSPENSION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3685-12ML - Milliliter0169-3685fb513715-528c-489c-88d7-39c4722bf43d12012-07-24

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
0169-3685NOVOLOG MIX 70/30 (INSULIN ASPART) INJECTION, SUSPENSION [NOVO NORDISK]24Current NDC, Legacy NDC, 4 package rows20230315_1861fcee-7673-4afe-a206-08fa05c0add2.zip

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 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
0169-3685-12001693685121 VIAL, GLASS in 1 CARTON (0169-3685-12) / 10 mL in 1 VIAL, GLASS2001-11-010000-00-00NoNoCurrent
0169-3685-92001693685921 VIAL, GLASS in 1 CARTON (0169-3685-92) > 10 mL in 1 VIAL, GLASS2001-11-010000-00-00NoNoCurrent