Home NDC 65649-551 Relistor
Product NDC 65649-551
11-digit product format 656490551
Labeler code 65649
Product ID 65649-551_9db15b8c-2928-4b75-a33b-548416afc8c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylnaltrexone bromide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Salix Pharmaceuticals, Inc.
Application NDA021964
Marketing category NDA
Marketing start 2008-04-24
Substance METHYLNALTREXONE BROMIDE
Active strength 12 mg/.6mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021964-001 RELISTOR METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 N021964-002 RELISTOR METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 N021964-003 RELISTOR METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27
Orange Book patents# Current patent rows page 1 of 1 · 21 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021964-001 12303592 2027-08-03 U-4197 Drug product 2025-06-12 N021964-001 12303592 2027-08-03 U-4198 Drug product 2025-06-12 N021964-001 8420663 2029-09-30 U-1185 2013-04-24 N021964-001 8822490 2029-09-30 U-1185 Drug product 2014-09-22 N021964-001 9180125 2029-09-30 U-1185 Drug product 2015-11-20 N021964-001 9492445 2029-09-30 U-1185 Drug product 2017-08-30 N021964-001 8247425 2030-12-31 U-1185 2012-09-13 N021964-002 12303592 2027-08-03 U-4197 Drug product 2025-06-12 N021964-002 12303592 2027-08-03 U-4198 Drug product 2025-06-12 N021964-002 8420663 2029-09-30 U-1185 N021964-002 8822490 2029-09-30 U-1185 Drug product 2014-09-22 N021964-002 9180125 2029-09-30 U-1185 Drug product 2015-11-20 N021964-002 9492445 2029-09-30 U-1185 Drug product 2017-08-30 N021964-002 8247425 2030-12-31 U-1185 N021964-003 12303592 2027-08-03 U-4197 Drug product 2025-06-12 N021964-003 12303592 2027-08-03 U-4198 Drug product 2025-06-12 N021964-003 8420663 2029-09-30 U-1185 N021964-003 8822490 2029-09-30 U-1185 Drug product 2014-09-22 N021964-003 9180125 2029-09-30 U-1185 Drug product 2015-11-20 N021964-003 9492445 2029-09-30 U-1185 Drug product 2017-08-30 N021964-003 8247425 2030-12-31 U-1185
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 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 24 · 951 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 N021964-001 12303592 2027-08-03 U-4197 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 12303592 2027-08-03 U-4198 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 8420663 2029-09-30 U-1185 2013-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 8822490 2029-09-30 U-1185 Drug product 2014-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 9180125 2029-09-30 U-1185 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 9492445 2029-09-30 U-1185 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-001 8247425 2030-12-31 U-1185 2012-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 12303592 2027-08-03 U-4197 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 12303592 2027-08-03 U-4198 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 8420663 2029-09-30 U-1185 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 8822490 2029-09-30 U-1185 Drug product 2014-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 9180125 2029-09-30 U-1185 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 9492445 2029-09-30 U-1185 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-002 8247425 2030-12-31 U-1185 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 12303592 2027-08-03 U-4197 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 12303592 2027-08-03 U-4198 Drug product 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 8420663 2029-09-30 U-1185 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 8822490 2029-09-30 U-1185 Drug product 2014-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 9180125 2029-09-30 U-1185 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 9492445 2029-09-30 U-1185 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021964-003 8247425 2030-12-31 U-1185 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 12303592 2027-08-03 U-4197 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 12303592 2027-08-03 U-4198 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 8420663 2029-09-30 U-1185 2013-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 8822490 2029-09-30 U-1185 Drug product 2014-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 9180125 2029-09-30 U-1185 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-001 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 N021964-001 8247425 2030-12-31 U-1185 2012-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 12303592 2027-08-03 U-4197 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 12303592 2027-08-03 U-4198 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 8420663 2029-09-30 U-1185 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 8822490 2029-09-30 U-1185 Drug product 2014-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 9180125 2029-09-30 U-1185 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-002 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 N021964-002 8247425 2030-12-31 U-1185 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 12303592 2027-08-03 U-4197 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 12303592 2027-08-03 U-4198 Drug product 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 8420663 2029-09-30 U-1185 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 8822490 2029-09-30 U-1185 Drug product 2014-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021964-003 9180125 2029-09-30 U-1185 Drug product 2015-11-20 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base Relistor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLNALTREXONE BROMIDE 12 mg/.6mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65649-551-02 Relistor 1 in 1 CARTON INJECTION, SOLUTION 1 68 65649-551-02 Relistor 0.6 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 0.6 68 65649-551-03 Relistor 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 68 65649-551-03 Relistor 7 in 1 CARTON INJECTION, SOLUTION 7 68 65649-551-07 Relistor 1 in 1 CARTON INJECTION, SOLUTION 1 68 65649-551-07 Relistor 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 68
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 65649-551 RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] 66 Current NDC, Legacy NDC, 6 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): 021964 application number: NDA021964 ndc (product): 65649-551
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65649-551-02 65649055102 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE 2008-04-24 0000-00-00 No No Current 65649-551-03 65649055103 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE 7 blister pack 2008-04-24 0000-00-00 No No Current 65649-551-07 65649055107 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE 1 blister pack 2008-04-24 0000-00-00 No No Current