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United States · US · US:59148-020_96cac6b9-6a43-4a69-ae83-fa739f14237d
SAMSCA
Orange BookUNIISPLATC C03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOtsuka America Pharmaceutical, Inc.
CountryUS (United States)
ATC codeC03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159148020501 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
21G72T1950
TOLVAPTAN
RxCUI 358257
Orange Book
N022275
AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "21G72T1950",
"rxcui": "358257",
"inchikey": "GYHCTFXIZSNGJT-UHFFFAOYSA-N",
"display_name": "TOLVAPTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5526617c-c7b9-4556-886d-729bbabbc566": {
"match": "brand_token",
"title": "SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
"spl_version": "23",
"published_date": "2026-06-01"
}
},
"productid": "59148-020_96cac6b9-6a43-4a69-ae83-fa739f14237d",
"productndc": "59148-020",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022275",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "15MG",
"product_no": "001",
"approval_date": "May 19, 2009"
},
{
"rs": true,
"rld": true,
"te_code": "AB1",
"strength": "30MG",
"product_no": "002",
"approval_date": "May 19, 2009"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "May 19, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOLVAPTAN",
"proprietary_name": "SAMSCA",
"active_ingred_unit": "mg/1",
"application_number": "NDA022275",
"marketing_category": "NDA",
"nonproprietary_name": "tolvaptan",
"start_marketing_date": "20090519",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code C03XA01.
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