SYMPROIC

Product NDC: 59385-041
11-digit product format: 593850041
Labeler code: 59385
Product ID: 59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naldemedine
Dosage form: TABLET
Route: ORAL
Labeler: BioDelivery Sciences International Inc
Application: NDA208854
Marketing category: NDA
Marketing start: 2019-06-14
Substance: NALDEMEDINE TOSYLATE
Active strength: .2 mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59385-041	59385-041-07	D	Discontinued by firm		2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59385-041	59385-041-07	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59385-041	59385-041-07	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`d06236e962d9…`

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALDEMEDINE TOSYLATE	.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1N8F1RVVO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1876603	Internal RxNorm lookup
1876609	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
b1a1256c-a1eb-4abe-ab1e-30e4711afd16	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41abf4a1-885f-4fc7-b2a9-9b351a7ae4ea	Product name	1	20170608

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59385-041-07	2021-07-30	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-30	2021-07-30	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-90	2021-07-30	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-07	2021-07-23	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-30	2021-07-23	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-90	2021-07-23	These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59385-041-07	SYMPROIC	7 in 1 BLISTER PACK	TABLET	7	10
59385-041-07	SYMPROIC	1 in 1 CARTON	TABLET	1	10
59385-041-30	SYMPROIC	30 in 1 BOTTLE, PLASTIC	TABLET	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59385-041-30	EA - Each	59385-041	a629b9ab-7e6c-40f7-8c04-7a2784ecd8dc	1	2019-07-02
59385-041-90	EA - Each	59385-041	fdc9aae2-e7c6-4f83-a146-aca2df5a3268	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59385-041	SYMPROIC (NALDEMEDINE) TABLET [BIODELIVERY SCIENCES INTERNATIONAL INC]	9	Current NDC, Legacy NDC, 3 package rows	20221227_b1a1256c-a1eb-4abe-ab1e-30e4711afd16.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
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 ndc (product): 59385-041

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1876603	naldemedine 0.2 MG Oral Tablet	PSN	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10
1876609	Symproic 0.2 MG Oral Tablet	PSN	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10
1876609	naldemedine 0.2 MG Oral Tablet [Symproic]	SBD	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10
1876603	naldemedine 0.2 MG Oral Tablet	SCD	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10
1876603	naldemedine (as naldemedine tosylate) 0.2 MG Oral Tablet	SY	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10
1876609	Symproic 0.2 MG Oral Tablet	SY	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59385-041-07	59385004107	1 BLISTER PACK in 1 CARTON (59385-041-07) > 7 TABLET in 1 BLISTER PACK	1 blister pack	2020-07-01	0000-00-00	No	No	Current
59385-041-30	59385004130	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)	30 tablet	2019-06-14	0000-00-00	No	No	Current