Trelstar

Product NDC: 0023-5906
11-digit product format: 000235906
Labeler code: 0023
Product ID: 0023-5906_935a48d7-3602-41a1-8f85-8063b1f2ca7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triptorelin pamoate
Dosage form: KIT
Labeler: Allergan, Inc.
Application: NDA022437
Marketing category: NDA
Marketing start: 2010-03-11
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0023-5906		D	Discontinued by firm		2026-10-05
excluded package	package	0023-5906	0023-5906-23	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0023-5906-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0023-5906-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0023-5906-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0023-5906-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0023-5906-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0023-5906-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0023-5906-23	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0023-5906-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0023-5906-23	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0023-5906-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0023-5906-23	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0023-5906-23	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022437-001	TRELSTAR	TRIPTORELIN PAMOATE	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR		RLD, RS	2010-03-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022437-001	10166181	2029-06-30		Drug product	2019-01-25

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.

Product history page 1 of 2 · 43 observed 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	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-5906-23	EA - Each	0023-5906	a389ba0f-dabc-421f-8655-96fe5c41023a	1	2017-07-07

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
Trelstar	TRIPTORELIN PAMOATE	Verity Pharmaceuticals Inc.	b1b84d62-a369-a4b7-5c41-dd1f553a18f3	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022437 application number: NDA022437

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08AN7WA2G0	TRIPTORELIN PAMOATE	124508-66-3	triptorelin pamoate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-5906-23	00023590623	1 KIT in 1 CARTON (0023-5906-23) * 2 mL in 1 VIAL, SINGLE-DOSE * 2 mL in 1 SYRINGE	1 kit	2010-03-11	0000-00-00	No	No	Current