Symproic

Product NDC: 59011-523
11-digit product format: 590110523
Labeler code: 59011
Product ID: 59011-523_340af158-2ff5-30f1-26e0-b60882e7c144
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naldemedine
Dosage form: TABLET
Route: ORAL
Labeler: Purdue Pharma LP
Application: NDA208854
Marketing category: NDA
Marketing start: 2017-03-23
Marketing end: 2020-12-31
Substance: NALDEMEDINE TOSYLATE
Active strength: 0 mg/1
Pharmacologic classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59011-523		D	Discontinued by firm	2026-09-14
excluded package	package	59011-523	59011-523-07	D	Discontinued by firm	2026-09-14
excluded package	package	59011-523	59011-523-30	D	Discontinued by firm	2026-09-14
excluded package	package	59011-523	59011-523-90	D	Discontinued by firm	2026-09-14

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 · 48 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	59011-523-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59011-523-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59011-523-07	`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	59011-523-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59011-523-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59011-523-07	`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	59011-523-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59011-523-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59011-523-07	`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	59011-523-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59011-523-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59011-523-07	`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	59011-523-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59011-523-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59011-523-07	`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	59011-523-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59011-523-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59011-523-07	`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	59011-523-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59011-523-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59011-523-07	`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	59011-523-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59011-523-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59011-523-07	`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	59011-523-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59011-523-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59011-523-07	`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	59011-523-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59011-523-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59011-523-07	`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	59011-523-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59011-523-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59011-523-07	`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	59011-523-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59011-523-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59011-523-07	`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
N208854-001	SYMPROIC	NALDEMEDINE TOSYLATE	EQ 0.2MG BASE	TABLET / ORAL		RLD, RS	2017-03-23

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02
N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02
N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31
N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21
N208854-001	12350377	2033-05-13		Drug product	2025-07-11

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	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 170 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	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208854-001	NCE	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208854-001	NCE	2022-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208854-001	NCE	2022-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208854-001	NCE	2022-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208854-001	NCE	2022-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208854-001	NCE	2022-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208854-001	NCE	2022-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208854-001	NCE	2022-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208854-001	NCE	2022-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208854-001	NCE	2022-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208854-001	NCE	2022-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208854-001	NCE	2022-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208854-001	NCE	2022-03-23	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208854-001	NCE	2022-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208854-001	NCE	2022-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208854-001	NCE	2022-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208854-001	NCE	2022-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208854-001	NCE	2022-03-23	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59011-523-30	EA - Each	59011-523	c81af6fe-fe16-46cc-8cdd-a239c03bcf05	1	2018-04-19
59011-523-90	EA - Each	59011-523	2cb4b3e3-27d6-4153-adef-fbad3d9a1588	1	2017-11-06

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
SYMPROIC	NALDEMEDINE	BioDelivery Sciences International Inc	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208854 application number: NDA208854

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1N8F1RVVO	NALDEMEDINE TOSYLATE	1345728-04-2	NALDEMEDINE TOSYLATE
03KSI6WLXH	NALDEMEDINE	916072-89-4	naldemedine

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Symproic	Purdue Pharma LP \| Shionogi Inc. \| Quotient Sciences - Philadelphia, LLC	2018-01-05	HUMAN PRESCRIPTION DRUG LABEL	8