FDA.reportPublic FDA data

NovoLog Mix 70/30

Product NDC
50090-2273
11-digit product format
500902273
Labeler code
50090
Product ID
50090-2273_54eed39e-7aff-446e-b6ea-475d77c9207c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA021172
Marketing category
BLA
Marketing start
2001-11-01
Marketing end
0000-00-00
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS],Insulin Analog [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2273-02023-02-07C16284748780-1f386c64a-3c77-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NOVOLOG MIX 70/30 safely and effectively. See full prescribing information for NOVOLOG MIX 70/30. NOVOLOG ® MIX 70/30 (insulin aspart protamine and insulin aspart) injectable suspension, for subcutaneous use Initial U.S. Approval: 2001
50090-2273-02023-01-30C16284748780-1f386c64a-3c77-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NOVOLOG MIX 70/30 safely and effectively. See full prescribing information for NOVOLOG MIX 70/30. NOVOLOG ® MIX 70/30 (insulin aspart protamine and insulin aspart) injectable suspension, for subcutaneous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2273-0NOVOLOG MIX 70/3010 mL in 1 VIAL, GLASSINJECTION, SUSPENSION1032
50090-2273-0NOVOLOG MIX 70/301 in 1 CARTONINJECTION, SUSPENSION132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2273-0ML - Milliliter50090-22733c915b59-0ffa-4bfa-9b04-eaeeb91233df12019-02-13

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2273-0500902273001 VIAL, GLASS in 1 CARTON (50090-2273-0) > 10 mL in 1 VIAL, GLASS2015-12-150000-00-00NoNoCurrent