MOVANTIK

Product NDC
82625-8802
11-digit product format
826258802
Labeler code
82625
Product ID
82625-8802_6747ab38-787e-4cd4-9626-b79b0432bc36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxegol oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Valinor Pharma, LLC
Application
NDA204760
Marketing category
NDA
Marketing start
2023-03-28
Substance
NALOXEGOL OXALATE
Active strength
25 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16caaa826d4ba7…
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…

Observed Orange Book patent history#

Patent history page 1 of 10 · 380 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204760-00177861332028-09-16Drug substance, Drug product2014-10-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204760-00190124692032-04-02Drug substance, Drug product2015-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N204760-00277861332028-09-16Drug substance, Drug product2014-10-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204760-00290124692032-04-02Drug substance, Drug product2015-05-15caaa826d4ba7…
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…

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXEGOL OXALATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
65I14TNM33Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1551782Internal RxNorm lookup
1551917Internal RxNorm lookup
1551923Internal RxNorm lookup
1601373Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28596788-b73f-4247-85fc-3105f51fff5aAvailable on FDA.report

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
82625-8802-1MOVANTIK30 in 1 BOTTLETABLET, FILM COATED303
82625-8802-2MOVANTIK90 in 1 BOTTLETABLET, FILM COATED903
82625-8802-3MOVANTIK10 in 1 CARTONTABLET, FILM COATED103
82625-8802-3MOVANTIK10 in 1 BLISTER PACKTABLET, FILM COATED103
82625-8802-4MOVANTIK1 in 1 CARTONTABLET, FILM COATED13
82625-8802-4MOVANTIK3 in 1 BLISTER PACKTABLET, FILM COATED33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82625-8802-1EA - Each82625-880268a1e915-e964-4ac1-a174-6ccd4082927912023-09-05
82625-8802-3EA - Each82625-8802ae9f2a6b-7292-450d-9a33-8166abce47a412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82625-8802MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [VALINOR PHARMA, LLC]2Current NDC, 6 package rows20241206_28596788-b73f-4247-85fc-3105f51fff5a.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
ndc (product): 82625-8802
MOVANTIKNALOXEGOL OXALATERedHill Biopharma Ltd300a6474-ebcd-4404-8040-48fdcfcc16352024-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 204760
application number: NDA204760

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551923movantik 12.5 MG Oral TabletPSN28596788-b73f-4247-85fc-3105f51fff5a3
1601373movantik 25 MG Oral TabletPSN28596788-b73f-4247-85fc-3105f51fff5a3
1551917naloxegol 12.5 MG Oral TabletPSN28596788-b73f-4247-85fc-3105f51fff5a3
1551782naloxegol 25 MG Oral TabletPSN28596788-b73f-4247-85fc-3105f51fff5a3
1551923naloxegol 12.5 MG Oral Tablet [Movantik]SBD28596788-b73f-4247-85fc-3105f51fff5a3
1601373naloxegol 25 MG Oral Tablet [Movantik]SBD28596788-b73f-4247-85fc-3105f51fff5a3
1551917naloxegol 12.5 MG Oral TabletSCD28596788-b73f-4247-85fc-3105f51fff5a3
1551782naloxegol 25 MG Oral TabletSCD28596788-b73f-4247-85fc-3105f51fff5a3
1551923Movantik 12.5 MG (as naloxegol oxalate 14.2 MG) Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3
1551923Movantik 12.5 MG Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3
1601373Movantik 25 MG (as naloxegol oxalate 28.5 MG) Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3
1601373Movantik 25 MG Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3
1551917naloxegol 12.5 MG (as naloxegol oxalate 14.2 MG) Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3
1551782naloxegol 25 MG (as naloxegol oxalate 28.5 MG) Oral TabletSY28596788-b73f-4247-85fc-3105f51fff5a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82625-8802-18262588020130 TABLET, FILM COATED in 1 BOTTLE (82625-8802-1) 2023-03-28NoNoCurrent
82625-8802-28262588020290 TABLET, FILM COATED in 1 BOTTLE (82625-8802-2) 2023-03-28NoNoCurrent
82625-8802-38262588020310 BLISTER PACK in 1 CARTON (82625-8802-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2023-03-28NoNoCurrent
82625-8802-4826258802041 BLISTER PACK in 1 CARTON (82625-8802-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-03-28YesNoCurrent