FDA.reportPublic FDA data

TRYNGOLZA

Product NDC
71860-101
11-digit product format
718600101
Labeler code
71860
Product ID
71860-101_55b4730e-4610-c0f2-e063-6294a90a90ae
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
Pharmacologic classes
APOC-III-directed RNA Interaction [EPC], Antisense Oligonucleotide [EPC], Antisense [CS], Increased RNA Degradation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218614-001TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUMEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19
N218614-002TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUMEQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-06-24

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218614-00191570822032-04-27U-40502025-01-16
N218614-00191570822032-04-27U-45802025-01-16
N218614-00195933332034-02-14U-40502025-01-16
N218614-001125096842034-05-01U-40502026-01-28
N218614-001125096842034-05-01U-45802026-01-28
N218614-00191272762034-05-01Drug substance2025-01-16
N218614-00191632392034-05-01Drug substance2025-01-16
N218614-00191815492034-05-01Drug substance2025-01-16
N218614-00291570822032-04-27U-45802026-07-22
N218614-002125096842034-05-01U-45802026-07-22
N218614-00291272762034-05-01Drug substance2026-07-22
N218614-00291632392034-05-01Drug substance2026-07-22
N218614-00291815492034-05-01Drug substance2026-07-22

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218614-001I-9922029-06-24
N218614-001ODE-5152031-12-19
N218614-002NS2029-06-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-1984e616aacf4f…
2026-09-14 22:38:342026-08N218614-002TRYNGOLZA (AUTOINJECTOR)EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-002TRYNGOLZA (AUTOINJECTOR)EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-1903ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218614-001TRYNGOLZA (AUTOINJECTOR)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-12-19a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218614-00191570822032-04-27U-40502025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-00191570822032-04-27U-45802025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-00195933332034-02-14U-40502025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-001125096842034-05-01U-40502026-01-2884e616aacf4f…
2026-09-14 22:38:342026-08N218614-001125096842034-05-01U-45802026-01-2884e616aacf4f…
2026-09-14 22:38:342026-08N218614-00191272762034-05-01Drug substance2025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-00191632392034-05-01Drug substance2025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-00191815492034-05-01Drug substance2025-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N218614-00291570822032-04-27U-45802026-07-2284e616aacf4f…
2026-09-14 22:38:342026-08N218614-002125096842034-05-01U-45802026-07-2284e616aacf4f…
2026-09-14 22:38:342026-08N218614-00291272762034-05-01Drug substance2026-07-2284e616aacf4f…
2026-09-14 22:38:342026-08N218614-00291632392034-05-01Drug substance2026-07-2284e616aacf4f…
2026-09-14 22:38:342026-08N218614-00291815492034-05-01Drug substance2026-07-2284e616aacf4f…
2026-08-18 06:07:402026-07N218614-00191570822032-04-27U-40502025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00191570822032-04-27U-45802025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00195933332034-02-14U-40502025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-001125096842034-05-01U-40502026-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-001125096842034-05-01U-45802026-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00191272762034-05-01Drug substance2025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00191632392034-05-01Drug substance2025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00191815492034-05-01Drug substance2025-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00291570822032-04-27U-45802026-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-002125096842034-05-01U-45802026-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00291272762034-05-01Drug substance2026-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00291632392034-05-01Drug substance2026-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-00291815492034-05-01Drug substance2026-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218614-00191570822032-04-27U-40502025-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218614-00195933332034-02-14U-40502025-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218614-001125096842034-05-01U-40502026-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218614-00191272762034-05-01Drug substance2025-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218614-00191632392034-05-01Drug substance2025-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218614-00191815492034-05-01Drug substance2025-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-00191570822032-04-27U-40502025-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-00195933332034-02-14U-40502025-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-00191272762034-05-01Drug substance2025-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-00191632392034-05-01Drug substance2025-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-00191815492034-05-01Drug substance2025-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N218614-00191570822032-04-27U-40502025-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218614-00195933332034-02-14U-40502025-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218614-00191272762034-05-01Drug substance2025-01-166a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218614-001I-9922029-06-2484e616aacf4f…
2026-09-14 22:38:342026-08N218614-001ODE-5152031-12-1984e616aacf4f…
2026-09-14 22:38:342026-08N218614-002NS2029-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N218614-001I-9922029-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-001ODE-5152031-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218614-002NS2029-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218614-001ODE-5152031-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218614-001ODE-5152031-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N218614-001ODE-5152031-12-196a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218614-001ODE-5152031-12-19a50c72e98297…

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
TRYNGOLZA
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NSY2BY6PSBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2701422Internal RxNorm lookup
2701428Internal RxNorm lookup
2746496Internal RxNorm lookup
2746499Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f51aa8e-8475-8cf9-e063-6394a90a6848Available on FDA.report

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

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
TRYNGOLZAOLEZARSEN SODIUMIonis Pharmaceuticals, Inc.0f51aa8e-8475-8cf9-e063-6394a90a68482026-07-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 218614
application number: NDA218614
ndc (product): 71860-101

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, GLASS2024-12-19NoNoCurrent