FDA.reportPublic FDA data

Enoxiluv Kit

Product NDC
76420-532
11-digit product format
764200532
Labeler code
76420
Product ID
76420-532_23b404bb-1707-b1ca-e063-6294a90adaff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium, Isopropyl Alcohol
Dosage form
KIT
Route
SUBCUTANEOUS; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-02-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
854235Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8855fae-f70d-4099-969e-a1d9f2929259Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33a7d2c8-f5cf-4d97-8510-92190c5e0f12Product name720240606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3246-64Enoxiluv Kit0.4 mL in 1 SYRINGEINJECTION0.4 mL100 mg in 1mL3
0781-3246-64Enoxiluv Kit10 in 1 CARTONINJECTION100 mg in 1mL3
76420-532-01Enoxiluv Kit1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-532-01EA - Each76420-53214f459c3-fb65-40b7-a1d5-0f0243b51e8112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-532ENOXILUV KIT (ENOXAPARIN SODIUM, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]3Current NDC, 3 package rows20241008_e8855fae-f70d-4099-969e-a1d9f2929259.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
Enoxiluv KitENOXAPARIN SODIUM, ISOPROPYL ALCOHOLAsclemed USA, Inc.e8855fae-f70d-4099-969e-a1d9f29292592024-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 76420-532

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNe8855fae-f70d-4099-969e-a1d9f29292593
797544isopropyl alcohol 70 % Medicated PadPSNe8855fae-f70d-4099-969e-a1d9f29292593
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDe8855fae-f70d-4099-969e-a1d9f29292593
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe8855fae-f70d-4099-969e-a1d9f29292593
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYe8855fae-f70d-4099-969e-a1d9f29292593
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYe8855fae-f70d-4099-969e-a1d9f29292593
797544isopropyl alcohol 70 % Medicated PadSYe8855fae-f70d-4099-969e-a1d9f29292593
797544isopropyl alcohol 70 % Topical ClothSYe8855fae-f70d-4099-969e-a1d9f29292593
797544isopropyl alcohol 70 % Topical SwabSYe8855fae-f70d-4099-969e-a1d9f29292593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3246-64007813246640.4 mL in 1 SYRINGE0.4 mlHistorical
76420-532-01764200532011 KIT in 1 CARTON (76420-532-01) * 10 SYRINGE in 1 CARTON (0781-3246-64) / .4 mL in 1 SYRINGE * 5 mL in 1 POUCH1 kit2023-02-08NoNoCurrent