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United States · US · US:82625-8801_6747ab38-787e-4cd4-9626-b79b0432bc36
MOVANTIK
Orange BookUNIISPLATC A06AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerValinor Pharma, LLC
CountryUS (United States)
ATC codeA06AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11826258801130 TABLET, FILM COATED in 1 BOTTLE (82625-8801-1)
- ndc11826258801290 TABLET, FILM COATED in 1 BOTTLE (82625-8801-2)
- ndc11826258801310 BLISTER PACK in 1 CARTON (82625-8801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1182625880141 BLISTER PACK in 1 CARTON (82625-8801-4) / 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": "82625-8801_6747ab38-787e-4cd4-9626-b79b0432bc36",
"productndc": "82625-8801",
"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": "20230328",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code A06AH03.
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