TRYNGOLZA

Product NDC: 71860-102
Requested package NDC: 71860-102-01
11-digit product format: 718600102
Labeler code: 71860
Product ID: 71860-102_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: 2026-06-24
Substance: OLEZARSEN SODIUM
Active strength: 50 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218614-001	TRYNGOLZA (AUTOINJECTOR)	OLEZARSEN SODIUM	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-12-19
N218614-002	TRYNGOLZA (AUTOINJECTOR)	OLEZARSEN SODIUM	EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2026-06-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218614-001	9157082	2032-04-27	U-4050		2025-01-16
N218614-001	9157082	2032-04-27	U-4580		2025-01-16
N218614-001	9593333	2034-02-14	U-4050		2025-01-16
N218614-001	12509684	2034-05-01	U-4050		2026-01-28
N218614-001	12509684	2034-05-01	U-4580		2026-01-28
N218614-001	9127276	2034-05-01		Drug substance	2025-01-16
N218614-001	9163239	2034-05-01		Drug substance	2025-01-16
N218614-001	9181549	2034-05-01		Drug substance	2025-01-16
N218614-002	9157082	2032-04-27	U-4580		2026-07-22
N218614-002	12509684	2034-05-01	U-4580		2026-07-22
N218614-002	9127276	2034-05-01		Drug substance	2026-07-22
N218614-002	9163239	2034-05-01		Drug substance	2026-07-22
N218614-002	9181549	2034-05-01		Drug substance	2026-07-22

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218614-001	I-992	2029-06-24
N218614-001	ODE-515	2031-12-19
N218614-002	NS	2029-06-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	TRYNGOLZA (AUTOINJECTOR)	EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	TRYNGOLZA (AUTOINJECTOR)	EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218614-001	TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-12-19	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218614-001	9157082	2032-04-27	U-4050		2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	9157082	2032-04-27	U-4580		2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	9593333	2034-02-14	U-4050		2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	12509684	2034-05-01	U-4050		2026-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	12509684	2034-05-01	U-4580		2026-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	9127276	2034-05-01		Drug substance	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	9163239	2034-05-01		Drug substance	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	9181549	2034-05-01		Drug substance	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	9157082	2032-04-27	U-4580		2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	12509684	2034-05-01	U-4580		2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	9127276	2034-05-01		Drug substance	2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	9163239	2034-05-01		Drug substance	2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	9181549	2034-05-01		Drug substance	2026-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218614-001	9157082	2032-04-27	U-4050		2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	9157082	2032-04-27	U-4580		2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	9593333	2034-02-14	U-4050		2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	12509684	2034-05-01	U-4050		2026-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	12509684	2034-05-01	U-4580		2026-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	9127276	2034-05-01		Drug substance	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	9163239	2034-05-01		Drug substance	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	9181549	2034-05-01		Drug substance	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	9157082	2032-04-27	U-4580		2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	12509684	2034-05-01	U-4580		2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	9127276	2034-05-01		Drug substance	2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	9163239	2034-05-01		Drug substance	2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	9181549	2034-05-01		Drug substance	2026-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218614-001	9157082	2032-04-27	U-4050		2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218614-001	9593333	2034-02-14	U-4050		2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218614-001	12509684	2034-05-01	U-4050		2026-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218614-001	9127276	2034-05-01		Drug substance	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218614-001	9163239	2034-05-01		Drug substance	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218614-001	9181549	2034-05-01		Drug substance	2025-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	9157082	2032-04-27	U-4050		2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	9593333	2034-02-14	U-4050		2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	9127276	2034-05-01		Drug substance	2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	9163239	2034-05-01		Drug substance	2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	9181549	2034-05-01		Drug substance	2025-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218614-001	9157082	2032-04-27	U-4050		2025-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218614-001	9593333	2034-02-14	U-4050		2025-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218614-001	9127276	2034-05-01		Drug substance	2025-01-16	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218614-001	I-992	2029-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-001	ODE-515	2031-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218614-002	NS	2029-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218614-001	I-992	2029-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-001	ODE-515	2031-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218614-002	NS	2029-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218614-001	ODE-515	2031-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218614-001	ODE-515	2031-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218614-001	ODE-515	2031-12-19	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218614-001	ODE-515	2031-12-19	`a50c72e98297…`

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
Ingredient	Strength
OLEZARSEN SODIUM	50 mg/.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NSY2BY6PSB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0f51aa8e-8475-8cf9-e063-6394a90a6848	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14132122-0a75-4b88-94e5-e31b2fd50013	Product name	1	20250814
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRYNGOLZA	OLEZARSEN SODIUM	Ionis Pharmaceuticals, Inc.	0f51aa8e-8475-8cf9-e063-6394a90a6848	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218614 application number: NDA218614 ndc (package): 71860-102-01 ndc (product): 71860-102 ndc11 (package): 71860010201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2701422	olezarsen 80 MG in 0.8 ML Auto-Injector	PSN	0f51aa8e-8475-8cf9-e063-6394a90a6848	6
2701428	Tryngolza 80 MG in 0.8 ML Auto-Injector	PSN	0f51aa8e-8475-8cf9-e063-6394a90a6848	6
2701428	0.8 ML olezarsen 100 MG/ML Auto-Injector [Tryngolza]	SBD	0f51aa8e-8475-8cf9-e063-6394a90a6848	6
2701422	0.8 ML olezarsen 100 MG/ML Auto-Injector	SCD	0f51aa8e-8475-8cf9-e063-6394a90a6848	6
2701422	olezarsen 80 MG (equivalent to olezarsen sodium 84 MG) per 0.8 ML Auto-Injector	SY	0f51aa8e-8475-8cf9-e063-6394a90a6848	6
2701428	Tryngolza 80 MG (equivalent to olezarsen sodium 84 MG ) per 0.8 ML Auto-Injector	SY	0f51aa8e-8475-8cf9-e063-6394a90a6848	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71860-102-01	71860010201	1 SYRINGE, GLASS in 1 CARTON (71860-102-01) / .8 mL in 1 SYRINGE, GLASS	2026-06-24	No	No	Current