FDA.reportPublic FDA data

TRYNGOLZA

Product NDC
71860-101
11-digit product format
718600101
Labeler code
71860
Product ID
71860-101_34f9bf77-6d88-5782-e063-6294a90a6c54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olezarsen sodium
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Ionis Pharmaceuticals, Inc.
Application
NDA218614
Marketing category
NDA
Marketing start
2024-12-19
Substance
OLEZARSEN SODIUM
Active strength
80 mg/.8mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLEZARSEN SODIUM80 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNSY2BY6PSB
Rxcui2701422, 2701428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14132122-0a75-4b88-94e5-e31b2fd50013Product name120250814
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71860-101-01TRYNGOLZA0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.86
71860-101-01TRYNGOLZA1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71860-101-01ML - Milliliter71860-1010fb6d9a5-2619-4eaa-a1d2-bdf5f010cd7f12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71860-101TRYNGOLZA (OLEZARSEN SODIUM) INJECTION, SOLUTION [IONIS PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20250514_0f51aa8e-8475-8cf9-e063-6394a90a6848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2701422olezarsen 80 MG in 0.8 ML Auto-InjectorPSN0f51aa8e-8475-8cf9-e063-6394a90a68486
2701428Tryngolza 80 MG in 0.8 ML Auto-InjectorPSN0f51aa8e-8475-8cf9-e063-6394a90a68486
27014280.8 ML olezarsen 100 MG/ML Auto-Injector [Tryngolza]SBD0f51aa8e-8475-8cf9-e063-6394a90a68486
27014220.8 ML olezarsen 100 MG/ML Auto-InjectorSCD0f51aa8e-8475-8cf9-e063-6394a90a68486
2701422olezarsen 80 MG (equivalent to olezarsen sodium 84 MG) per 0.8 ML Auto-InjectorSY0f51aa8e-8475-8cf9-e063-6394a90a68486
2701428Tryngolza 80 MG (equivalent to olezarsen sodium 84 MG ) per 0.8 ML Auto-InjectorSY0f51aa8e-8475-8cf9-e063-6394a90a68486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71860-101-01718600101011 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS2024-12-19NoNoHistorical