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United States · US · US:67877-635_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d
Tolvaptan
Orange BookUNIISPLATC C03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeC03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116787763501100 TABLET in 1 BOTTLE (67877-635-01)
- ndc11678776350210 TABLET in 1 BOTTLE (67877-635-02)
- ndc1167877635331 BLISTER PACK in 1 CARTON (67877-635-33) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
21G72T1950
TOLVAPTAN
RxCUI 358257
Orange Book
A211891
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": "67877-635_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d",
"productndc": "67877-635",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211891",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "May 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG",
"product_no": "002",
"approval_date": "May 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "15MG",
"product_no": "003",
"approval_date": "Sep 6, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOLVAPTAN",
"proprietary_name": "Tolvaptan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211891",
"marketing_category": "ANDA",
"nonproprietary_name": "Tolvaptan",
"start_marketing_date": "20220907",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code C03XA01.
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