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United States · US · US:72603-932_3dd69146-6f15-4c54-a6d9-7408e6c41548
TOLVAPTAN
Orange BookUNIISPLATC C03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar Rx LLC
CountryUS (United States)
ATC codeC03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
21G72T1950
TOLVAPTAN
RxCUI 358257
Orange Book
A216949
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": {
"c075d517-f4c8-469a-9f51-416ef61c6a83": {
"match": "brand_token",
"title": "TOLVAPTAN TABLET [NORTHSTAR RX LLC]",
"spl_version": "3",
"published_date": "2026-04-27"
}
},
"productid": "72603-932_3dd69146-6f15-4c54-a6d9-7408e6c41548",
"productndc": "72603-932",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216949",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "15MG",
"product_no": "001",
"approval_date": "Jun 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "002",
"approval_date": "Jun 21, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOLVAPTAN",
"proprietary_name": "TOLVAPTAN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216949",
"marketing_category": "ANDA",
"nonproprietary_name": "TOLVAPTAN",
"start_marketing_date": "20230621",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code C03XA01.
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