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
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y17CTI5SRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2179744Internal RxNorm lookup
2179749Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
afca6e80-a802-49fb-a978-5fe28a173001Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-01-30These 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
2024-01-30These 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
2023-08-21These 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
2023-08-21These 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
2023-07-28These 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
2023-07-28These 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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYXREDLININSULIN HUMANBaxter Healthcare Corporationafca6e80-a802-49fb-a978-5fe28a1730012025-03-07Warnings, Adverse reactionsExact identifier
application number: BLA208157
ndc (product): 0338-0126

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208157Myxredlininsulin human351(a)Rx2026-07-01

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