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United States · US · US:54092-547_1278ace1-66f8-4bd8-8cf0-bd731f936563
MOTEGRITY
Orange BookUNIISPLATC A06AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA06AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11540925470130 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)
Annotations
UNII (FDA Substance ID)
4V2G75E1CK
PRUCALOPRIDE SUCCINATE
RxCUI 2107309
Orange Book
N210166
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4V2G75E1CK",
"rxcui": "2107309",
"inchikey": "QZRSNVSQLGRAID-UHFFFAOYSA-N",
"display_name": "PRUCALOPRIDE SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bca1e4c6-4b2b-4876-8ab3-654629c4ff1b": {
"match": "brand_token",
"title": "MOTEGRITY (PRUCALOPRIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "12",
"published_date": "2025-07-21"
}
},
"productid": "54092-547_1278ace1-66f8-4bd8-8cf0-bd731f936563",
"productndc": "54092-547",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210166",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Dec 14, 2018"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Dec 14, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRUCALOPRIDE SUCCINATE",
"proprietary_name": "MOTEGRITY",
"active_ingred_unit": "mg/1",
"application_number": "NDA210166",
"marketing_category": "NDA",
"nonproprietary_name": "PRUCALOPRIDE",
"start_marketing_date": "20181214",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code A06AX05.
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