FDA.reportPublic FDA data

MYXREDLIN

Product NDC
0338-0126
11-digit product format
003380126
Labeler code
0338
Product ID
0338-0126_b06f658e-e123-419e-8ea6-35c2ed654461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin human
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
BLA208157
Marketing category
BLA
Marketing start
2019-07-12
Substance
INSULIN HUMAN
Active strength
1 [iU]/mL
Pharmacologic classes
Insulin [CS], Insulin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MYXREDLIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN1 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui2179744, 2179749

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0338-0126-122024-01-30C16284748780-10191ceaa-6434-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MYXREDLIN safely and effectively. See full prescribing information for MYXREDLIN . MYXREDLIN (insulin human) in sodium chloride injection, for intravenous use Initial U.S. Approval: 2019
0338-0126-122023-08-21C16284748780-10191ceaa-6434-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MYXREDLIN safely and effectively. See full prescribing information for MYXREDLIN . MYXREDLIN (insulin human) in sodium chloride injection, for intravenous use Initial U.S. Approval: 2019
0338-0126-122023-07-28C16284748780-10191ceaa-6434-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MYXREDLIN safely and effectively. See full prescribing information for MYXREDLIN . MYXREDLIN (insulin human) in sodium chloride injection, for intravenous use Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0126-12MYXREDLIN100 mL in 1 CONTAINERINJECTION, SOLUTION10011
0338-0126-12MYXREDLIN12 in 1 CARTONINJECTION, SOLUTION1211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0126-12ML - Milliliter0338-012683aa9e2f-f988-4a22-8b5b-dc4ac7abbda112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0126MYXREDLIN (INSULIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10Current NDC, Legacy NDC, 2 package rows20250425_afca6e80-a802-49fb-a978-5fe28a173001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179749MYXREDLIN 100 UNT in 100 ML InjectionPSNafca6e80-a802-49fb-a978-5fe28a17300111
2179744regular insulin, human 100 UNT in 100 ML InjectionPSNafca6e80-a802-49fb-a978-5fe28a17300111
2179749100 ML insulin, regular, human 1 UNT/ML Injection [Myxredlin]SBDafca6e80-a802-49fb-a978-5fe28a17300111
2179744100 ML insulin, regular, human 1 UNT/ML InjectionSCDafca6e80-a802-49fb-a978-5fe28a17300111
2179749100 ML Myxredlin 1 UNT/ML InjectionSYafca6e80-a802-49fb-a978-5fe28a17300111
2179749Myxredlin 100 UNT per 100 ML InjectionSYafca6e80-a802-49fb-a978-5fe28a17300111
2179744regular insulin, human 100 UNT per 100 ML InjectionSYafca6e80-a802-49fb-a978-5fe28a17300111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0126-120033801261212 CONTAINER in 1 CARTON (0338-0126-12) / 100 mL in 1 CONTAINER12 container2019-07-120000-00-00NoNoCurrent