Relistor

Product NDC: 65649-150
11-digit product format: 656490150
Labeler code: 65649
Product ID: 65649-150_9db15b8c-2928-4b75-a33b-548416afc8c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylnaltrexone bromide
Dosage form: TABLET
Route: ORAL
Labeler: Salix Pharmaceuticals, Inc.
Application: NDA208271
Marketing category: NDA
Marketing start: 2008-08-01
Substance: METHYLNALTREXONE BROMIDE
Active strength: 150 mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	65649-150	65649-150-60	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

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

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
N208271-001	RELISTOR	METHYLNALTREXONE BROMIDE	150MG	TABLET / ORAL		RLD, RS	2016-07-19

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208271-001	8420663	2029-09-30	U-1185		2016-07-25
N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25
N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30
N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16
N208271-001	10307417	2031-03-10		Drug product	2019-06-07
N208271-001	10376505	2031-03-10		Drug product	2019-09-10
N208271-001	8524276	2031-03-10		Drug product	2016-07-25
N208271-001	8956651	2031-03-10		Drug product	2016-07-25
N208271-001	9314461	2031-03-10		Drug product	2016-08-12

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	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 368 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	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208271-001	NP	2019-07-19	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208271-001	NP	2019-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208271-001	NP	2019-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208271-001	NP	2019-07-19	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Relistor
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLNALTREXONE BROMIDE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RFO6IL3D3M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979113	Internal RxNorm lookup
979115	Internal RxNorm lookup
1244060	Internal RxNorm lookup
1244062	Internal RxNorm lookup
1244063	Internal RxNorm lookup
1244064	Internal RxNorm lookup
1801514	Internal RxNorm lookup
1801519	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
c488fb7c-0a5b-487c-b452-996809d1cb99	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d504bffe-70f9-e32d-e34e-5436c09079d4	Product name	3	20250325
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65649-150-06	Relistor	1 in 1 CARTON	TABLET	1	68
65649-150-06	Relistor	6 in 1 BOTTLE	TABLET	6	68
65649-150-60	Relistor	60 in 1 BOTTLE	TABLET	60	68
65649-150-90	Relistor	90 in 1 BOTTLE	TABLET	90	68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65649-150-90	EA - Each	65649-150	373069c0-4263-4edb-93fb-5901a479ffb7	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
METHYLNALTREXONE BROMIDE	ACTIVE INGREDIENT	RFO6IL3D3M	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
METHYLNALTREXONE	ACTIVE MOIETY	0RK7M7IABE	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
GLYCINE HYDROCHLORIDE	INACTIVE INGREDIENT	225ZLC74HX	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42
WATER	INACTIVE INGREDIENT	059QF0KO0R	RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65649-150	RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]	66	Current NDC, Legacy NDC, 4 package rows	20240516_c488fb7c-0a5b-487c-b452-996809d1cb99.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
Relistor	METHYLNALTREXONE BROMIDE	Salix Pharmaceuticals, Inc.	c488fb7c-0a5b-487c-b452-996809d1cb99	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208271 application number: NDA208271 ndc (product): 65649-150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RFO6IL3D3M	METHYLNALTREXONE BROMIDE	916055-92-0	METHYLNALTREXONE BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979113	methylnaltrexone bromide 12 MG in 0.6 ML Injection	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244060	methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801514	methylnaltrexone bromide 150 MG Oral Tablet	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244063	methylnaltrexone bromide 8 MG in 0.4 ML Prefilled Syringe	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979115	RELISTOR 12 MG in 0.6 ML Injection	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244062	RELISTOR 12 MG in 0.6 ML Prefilled Syringe	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801519	RELISTOR 150 MG Oral Tablet	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244064	RELISTOR 8 MG in 0.4 ML Prefilled Syringe	PSN	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244064	0.4 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe [Relistor]	SBD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979115	0.6 ML methylnaltrexone bromide 20 MG/ML Injection [Relistor]	SBD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244062	0.6 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe [Relistor]	SBD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801519	methylnaltrexone bromide 150 MG Oral Tablet [Relistor]	SBD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244063	0.4 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe	SCD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979113	0.6 ML methylnaltrexone bromide 20 MG/ML Injection	SCD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244060	0.6 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe	SCD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801514	methylnaltrexone bromide 150 MG Oral Tablet	SCD	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244064	0.4 ML Relistor 20 MG/ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979115	0.6 ML Relistor 20 MG/ML Injection	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244062	0.6 ML Relistor 20 MG/ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979113	methylnaltrexone bromide 12 MG per 0.6 ML Injection	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244060	methylnaltrexone bromide 12 MG per 0.6 ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801514	methylnaltrexone bromide 150 MG (equivalent to methylnaltrexone 122.5 MG) Oral Tablet	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244063	methylnaltrexone bromide 8 MG per 0.4 ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
979115	Relistor 12 MG per 0.6 ML Injection	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244062	Relistor 12 MG per 0.6 ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1801519	Relistor 150 MG (equivalent to methylnaltrexone 122.5 MG) Oral Tablet	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68
1244064	Relistor 8 MG per 0.4 ML Prefilled Syringe	SY	c488fb7c-0a5b-487c-b452-996809d1cb99	68

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65649-150-06	65649015006	1 BOTTLE in 1 CARTON (65649-150-06) / 6 TABLET in 1 BOTTLE	1 bottle	2016-07-19	0000-00-00	No	No	Current
65649-150-60	65649015060	60 in 1 BOTTLE						Historical
65649-150-90	65649015090	90 TABLET in 1 BOTTLE (65649-150-90)	90 tablet	2016-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Relistor	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	68