FDA.reportPublic FDA data

MOVANTIK

Product NDC
82625-8801
11-digit product format
826258801
Labeler code
82625
Product ID
82625-8801_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
12.5 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 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N204760-001MOVANTIKEQ 12.5MG BASETABLET / ORALRLD2014-09-16a50c72e98297…
2026-08-01 22:54:322026-06N204760-002MOVANTIKEQ 25MG BASETABLET / ORALRLD, RS2014-09-16a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N204760-00177861332028-09-16Drug substance, Drug product2014-10-14a50c72e98297…
2026-08-01 22:54:322026-06N204760-00190124692032-04-02Drug substance, Drug product2015-05-15a50c72e98297…
2026-08-01 22:54:322026-06N204760-00277861332028-09-16Drug substance, Drug product2014-10-14a50c72e98297…
2026-08-01 22:54:322026-06N204760-00290124692032-04-02Drug substance, Drug product2015-05-15a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 82625-8801
MOVANTIKNALOXEGOL OXALATERedHill Biopharma Ltd300a6474-ebcd-4404-8040-48fdcfcc16352024-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 204760
application number: NDA204760

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXEGOL OXALATE12.5 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
82625-8801-1MOVANTIK30 in 1 BOTTLETABLET, FILM COATED303
82625-8801-2MOVANTIK90 in 1 BOTTLETABLET, FILM COATED903
82625-8801-3MOVANTIK10 in 1 CARTONTABLET, FILM COATED103
82625-8801-3MOVANTIK10 in 1 BLISTER PACKTABLET, FILM COATED103
82625-8801-4MOVANTIK3 in 1 BLISTER PACKTABLET, FILM COATED33
82625-8801-4MOVANTIK1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82625-8801-1EA - Each82625-880146eb107d-759c-4ba9-9369-d5d45b3de4ca12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82625-8801MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [VALINOR PHARMA, LLC]2Current NDC, 6 package rows20241206_28596788-b73f-4247-85fc-3105f51fff5a.zip

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
82625-8801-18262588010130 TABLET, FILM COATED in 1 BOTTLE (82625-8801-1) 2023-03-28NoNoCurrent
82625-8801-28262588010290 TABLET, FILM COATED in 1 BOTTLE (82625-8801-2) 2023-03-28NoNoCurrent
82625-8801-38262588010310 BLISTER PACK in 1 CARTON (82625-8801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2023-03-28NoNoCurrent
82625-8801-4826258801041 BLISTER PACK in 1 CARTON (82625-8801-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-03-28YesNoCurrent