FDA.reportPublic FDA data

WAINUA

Product NDC
0310-9400
11-digit product format
003109400
Labeler code
0310
Product ID
0310-9400_cea076d0-c827-4c46-9b36-418bf63d5a9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPLONTERSEN
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA217388
Marketing category
NDA
Marketing start
2023-12-21
Substance
EPLONTERSEN
Active strength
45 mg/.8mL
Pharmacologic classes
Antisense Oligonucleotide [EPC], Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], Oligonucleotides, Antisense [CS], Transthyretin-directed RNA Interaction [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WAINUA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPLONTERSEN45 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0GRZ0F5XJ6
Rxcui2671944, 2671950, 2741485, 2741488

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7859a078-9f10-4873-a458-7b1d6707eae7Product name120250107
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-9400-01WAINUA1 in 1 CARTONINJECTION, SOLUTION120
0310-9400-01WAINUA0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-9400-01ML - Milliliter0310-940031d18847-e3ab-4358-86f9-58d276e4f58012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-9400WAINUA (EPLONTERSEN) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]9Current NDC, 2 package rows20250425_d7dcb847-71dd-4fff-82d0-d43a465fc096.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671944eplontersen 45 MG in 0.8 ML Auto-InjectorPSNd7dcb847-71dd-4fff-82d0-d43a465fc09620
2741485eplontersen 45 MG in 0.8 ML Prefilled SyringePSNd7dcb847-71dd-4fff-82d0-d43a465fc09620
2671950WAINUA 45 MG in 0.8 ML Auto-InjectorPSNd7dcb847-71dd-4fff-82d0-d43a465fc09620
2741488WAINUA 45 MG in 0.8 ML Prefilled SyringePSNd7dcb847-71dd-4fff-82d0-d43a465fc09620
26719500.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua]SBDd7dcb847-71dd-4fff-82d0-d43a465fc09620
27414880.8 ML eplontersen 56.3 MG/ML Prefilled Syringe [Wainua]SBDd7dcb847-71dd-4fff-82d0-d43a465fc09620
26719440.8 ML eplontersen 56.3 MG/ML Auto-InjectorSCDd7dcb847-71dd-4fff-82d0-d43a465fc09620
27414850.8 ML eplontersen 56.3 MG/ML Prefilled SyringeSCDd7dcb847-71dd-4fff-82d0-d43a465fc09620
2671944eplontersen 45 MG (as eplontersen sodium 47 MG) per 0.8 ML Auto-InjectorSYd7dcb847-71dd-4fff-82d0-d43a465fc09620
2741485eplontersen 45 MG (as eplontersen sodium 47 MG) per 0.8 ML Prefilled SyringeSYd7dcb847-71dd-4fff-82d0-d43a465fc09620
2671944eplontersen 56.25 MG/ML per 0.8 ML Auto-InjectorSYd7dcb847-71dd-4fff-82d0-d43a465fc09620
2671950Wainua 45 MG (as eplontersen sodium 47 MG) per 0.8 ML Auto-InjectorSYd7dcb847-71dd-4fff-82d0-d43a465fc09620
2741488Wainua 45 MG (as eplontersen sodium 47 MG) per 0.8 ML Prefilled SyringeSYd7dcb847-71dd-4fff-82d0-d43a465fc09620
2671950Wainua 56.25 MG/ML per 0.8 ML Auto-InjectorSYd7dcb847-71dd-4fff-82d0-d43a465fc09620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0310-9400-01003109400011 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS2023-12-21NoNoCurrent