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United States · US · US:57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb
MOVANTIK
Orange BookUNIISPLATC A06AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRedHill Biopharma Ltd
CountryUS (United States)
ATC codeA06AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11578411301130 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)
- ndc11578411301290 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)
- ndc11578411301310 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1157841130141 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
65I14TNM33
NALOXEGOL OXALATE
RxCUI 1593586
Orange Book
N204760
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "65I14TNM33",
"rxcui": "1593586",
"inchikey": "MNYIRXLCPODKLG-VUTNLTPYSA-N",
"display_name": "NALOXEGOL OXALATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"28596788-b73f-4247-85fc-3105f51fff5a": {
"match": "brand_token",
"title": "MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [VALINOR PHARMA, LLC]",
"spl_version": "3",
"published_date": "2025-12-23"
}
},
"productid": "57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb",
"productndc": "57841-1301",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204760",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 12.5MG BASE",
"product_no": "001",
"approval_date": "Sep 16, 2014"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Sep 16, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXEGOL OXALATE",
"proprietary_name": "MOVANTIK",
"active_ingred_unit": "mg/1",
"application_number": "NDA204760",
"marketing_category": "NDA",
"nonproprietary_name": "naloxegol oxalate",
"start_marketing_date": "20201001",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A06AH03.
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