Home DailyMed 32044b2f-5659-4da8-833e-960eaafe7e3e National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:28:31 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 22:38:34 2026-08 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021964-001 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 RELISTOR 8MG/0.4ML (8MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 RELISTOR 12MG/0.6ML (12MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-09-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 25 · 993 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 N021964-001 12303592 2027-08-03 U-4197 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 12303592 2027-08-03 U-4198 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 8420663 2029-09-30 U-1185 2013-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 8822490 2029-09-30 U-1185 Drug product 2014-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 9180125 2029-09-30 U-1185 Drug product 2015-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 9492445 2029-09-30 U-1185 Drug product 2017-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-001 8247425 2030-12-31 U-1185 2012-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 12303592 2027-08-03 U-4197 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 12303592 2027-08-03 U-4198 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 8420663 2029-09-30 U-1185 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 8822490 2029-09-30 U-1185 Drug product 2014-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 9180125 2029-09-30 U-1185 Drug product 2015-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 9492445 2029-09-30 U-1185 Drug product 2017-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-002 8247425 2030-12-31 U-1185 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 12303592 2027-08-03 U-4197 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 12303592 2027-08-03 U-4198 Drug product 2025-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 8420663 2029-09-30 U-1185 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 8822490 2029-09-30 U-1185 Drug product 2014-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 9180125 2029-09-30 U-1185 Drug product 2015-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 9492445 2029-09-30 U-1185 Drug product 2017-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021964-003 8247425 2030-12-31 U-1185 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021964-001 12303592 2027-08-03 U-4197 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 12303592 2027-08-03 U-4198 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 8420663 2029-09-30 U-1185 2013-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 8822490 2029-09-30 U-1185 Drug product 2014-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 9180125 2029-09-30 U-1185 Drug product 2015-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 9492445 2029-09-30 U-1185 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-001 8247425 2030-12-31 U-1185 2012-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 12303592 2027-08-03 U-4197 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 12303592 2027-08-03 U-4198 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 8420663 2029-09-30 U-1185 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 8822490 2029-09-30 U-1185 Drug product 2014-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 9180125 2029-09-30 U-1185 Drug product 2015-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 9492445 2029-09-30 U-1185 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-002 8247425 2030-12-31 U-1185 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 12303592 2027-08-03 U-4197 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 12303592 2027-08-03 U-4198 Drug product 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 8420663 2029-09-30 U-1185 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 8822490 2029-09-30 U-1185 Drug product 2014-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021964-003 9180125 2029-09-30 U-1185 Drug product 2015-11-20 caaa826d4ba7…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.