MOVANTIK

Product NDC
57841-1300
Requested package NDC
57841-1300-4
11-digit product format
578411300
Labeler code
57841
Product ID
57841-1300_046d2fd8-3056-425f-a196-7ff77450368c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxegol oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedHill Biopharma Ltd
Application
NDA204760
Marketing category
NDA
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
NALOXEGOL OXALATE
Active strength
13 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57841-130057841-1300-4DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57841-130057841-1300-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57841-130057841-1300-4DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204760-001MOVANTIKNALOXEGOL OXALATEEQ 12.5MG BASETABLET / ORALRLD2014-09-16
N204760-002MOVANTIKNALOXEGOL OXALATEEQ 25MG BASETABLET / ORALRLD, RS2014-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204760-00177861332028-09-16Drug substance, Drug product2014-10-14
N204760-00190124692032-04-02Drug substance, Drug product2015-05-15
N204760-00277861332028-09-16Drug substance, Drug product2014-10-14
N204760-00290124692032-04-02Drug substance, Drug product2015-05-15

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16782e0a99824c…
2021-12-28 21:50 UTC2021-12N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 10 · 376 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204760-00177861332028-09-16Drug substance, Drug product2014-10-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204760-00190124692032-04-02Drug substance, Drug product2015-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204760-00277861332028-09-16Drug substance, Drug product2014-10-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204760-00290124692032-04-02Drug substance, Drug product2015-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-00177861332028-09-16Drug substance, Drug product2014-10-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-00190124692032-04-02Drug substance, Drug product2015-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-00277861332028-09-16Drug substance, Drug product2014-10-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204760-00290124692032-04-02Drug substance, Drug product2015-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N204760-00177861332028-09-16Drug substance, Drug product2014-10-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204760-00190124692032-04-02Drug substance, Drug product2015-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204760-00277861332028-09-16Drug substance, Drug product2014-10-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204760-00290124692032-04-02Drug substance, Drug product2015-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-00177861332028-09-16Drug substance, Drug product2014-10-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-00190124692032-04-02Drug substance, Drug product2015-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-00277861332028-09-16Drug substance, Drug product2014-10-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204760-00290124692032-04-02Drug substance, Drug product2015-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-00177861332028-09-16Drug substance, Drug product2014-10-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-00190124692032-04-02Drug substance, Drug product2015-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-00277861332028-09-16Drug substance, Drug product2014-10-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204760-00290124692032-04-02Drug substance, Drug product2015-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00170565002024-06-29U-1185Drug product2015-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00180674312024-12-16U-11852014-10-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00177861332028-09-16Drug substance, Drug product2014-10-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00190124692032-04-02Drug substance, Drug product2015-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00270565002024-06-29U-1185Drug product2015-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00280674312024-12-16U-11852014-10-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00277861332028-09-16Drug substance, Drug product2014-10-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204760-00290124692032-04-02Drug substance, Drug product2015-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00170565002024-06-29U-1185Drug product2015-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00180674312024-12-16U-11852014-10-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00177861332028-09-16Drug substance, Drug product2014-10-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00190124692032-04-02Drug substance, Drug product2015-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00270565002024-06-29U-1185Drug product2015-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00280674312024-12-16U-11852014-10-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00277861332028-09-16Drug substance, Drug product2014-10-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204760-00290124692032-04-02Drug substance, Drug product2015-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-00170565002024-06-29U-1185Drug product2015-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-00180674312024-12-16U-11852014-10-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-00177861332028-09-16Drug substance, Drug product2014-10-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204760-00190124692032-04-02Drug substance, Drug product2015-05-155bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N204760-001NCE2019-09-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204760-002NCE2019-09-1674a2ff9319b5…
2019-12-14 00:12 UTC2019-12N204760-001NCE2019-09-163f01610625f2…
2019-12-14 00:12 UTC2019-12N204760-002NCE2019-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09N204760-001NCE2019-09-16b00525d2431f…
2019-09-15 20:21 UTC2019-09N204760-002NCE2019-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N204760-001NCE2019-09-16ea99ee380514…
2019-07-19 19:46 UTC2019-07N204760-002NCE2019-09-16ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
165eaa71-147c-4cfb-8922-5658e5aa4a66Product name120150327
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57841-1300-1MOVANTIK30 in 1 BOTTLETABLET, FILM COATED305
57841-1300-2MOVANTIK90 in 1 BOTTLETABLET, FILM COATED905
57841-1300-3MOVANTIK10 in 1 BLISTER PACKTABLET, FILM COATED105
57841-1300-3MOVANTIK10 in 1 CARTONTABLET, FILM COATED105
57841-1300-4MOVANTIK1 in 1 CARTONTABLET, FILM COATED15
57841-1300-4MOVANTIK3 in 1 BLISTER PACKTABLET, FILM COATED35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57841-1300MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD]5Legacy NDC, 6 package rows20241129_300a6474-ebcd-4404-8040-48fdcfcc1635.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOVANTIKNALOXEGOL OXALATEValinor Pharma, LLC28596788-b73f-4247-85fc-3105f51fff5a2025-12-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 204760
application number: NDA204760
MOVANTIKNALOXEGOL OXALATERedHill Biopharma Ltd300a6474-ebcd-4404-8040-48fdcfcc16352024-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 204760
application number: NDA204760
ndc (package): 57841-1300-4
ndc (product): 57841-1300
ndc11 (package): 57841130004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551923movantik 12.5 MG Oral TabletPSN300a6474-ebcd-4404-8040-48fdcfcc16355
1601373movantik 25 MG Oral TabletPSN300a6474-ebcd-4404-8040-48fdcfcc16355
1551917naloxegol 12.5 MG Oral TabletPSN300a6474-ebcd-4404-8040-48fdcfcc16355
1551782naloxegol 25 MG Oral TabletPSN300a6474-ebcd-4404-8040-48fdcfcc16355
1551923naloxegol 12.5 MG Oral Tablet [Movantik]SBD300a6474-ebcd-4404-8040-48fdcfcc16355
1601373naloxegol 25 MG Oral Tablet [Movantik]SBD300a6474-ebcd-4404-8040-48fdcfcc16355
1551917naloxegol 12.5 MG Oral TabletSCD300a6474-ebcd-4404-8040-48fdcfcc16355
1551782naloxegol 25 MG Oral TabletSCD300a6474-ebcd-4404-8040-48fdcfcc16355
1551923Movantik 12.5 MG (as naloxegol oxalate 14.2 MG) Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355
1551923Movantik 12.5 MG Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355
1601373Movantik 25 MG (as naloxegol oxalate 28.5 MG) Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355
1601373Movantik 25 MG Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355
1551917naloxegol 12.5 MG (as naloxegol oxalate 14.2 MG) Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355
1551782naloxegol 25 MG (as naloxegol oxalate 28.5 MG) Oral TabletSY300a6474-ebcd-4404-8040-48fdcfcc16355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57841-1300-4578411300041 BLISTER PACK in 1 CARTON (57841-1300-4) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-10-010000-00-00YesNoCurrent