FDA.reportPublic FDA data

.Insulin Aspart Protamine and Insulin Aspart

Product NDC
50090-4959
11-digit product format
500904959
Labeler code
50090
Product ID
50090-4959_6831854d-54bc-417d-8ddc-1cb93c534dda
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
.Insulin Aspart Protamine and Insulin Aspart
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui847191

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
50090-4959-02023-02-07C16284748780-1f386c64a-435d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 safely and effectively. See full prescribing information for INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30. INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 injectable suspension, for subcutaneous use Initial U.S. Approval: 2001 This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart).
50090-4959-02023-01-30C16284748780-1f386c64a-435d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 safely and effectively. See full prescribing information for INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30. INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 injectable suspension, for subcutaneous use Initial U.S. Approval: 2001 This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4959-0.Insulin Aspart Protamine and Insulin Aspart5 in 1 CARTONINJECTION, SUSPENSION510
50090-4959-0.Insulin Aspart Protamine and Insulin Aspart3 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4959-0ML - Milliliter50090-49597e2de542-073d-4d46-895a-f10da3146ede12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4959.INSULIN ASPART PROTAMINE AND INSULIN ASPART (INSULIN ASPART) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240224_14499781-b90e-47d5-a7de-006965439b94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847191insulin aspart protamine / insulin aspart 70/30 in 3 ML Pen InjectorPSN14499781-b90e-47d5-a7de-006965439b9410
8471913 ML insulin aspart protamine, human 70 UNT/ML / insulin aspart, human 30 UNT/ML Pen InjectorSCD14499781-b90e-47d5-a7de-006965439b9410
847191insulin, aspart protamine, human 70 UNT/ML / insulin, aspart, human 30 UNT/ML per 3 ML Pen InjectorSY14499781-b90e-47d5-a7de-006965439b9410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4959-0500904959005 SYRINGE, PLASTIC in 1 CARTON (50090-4959-0) / 3 mL in 1 SYRINGE, PLASTIC2020-03-120000-00-00NoNoCurrent