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United States · US · US:31722-869_e7e86fa1-8352-5245-e053-2995a90a70f6
Tolvaptan
Orange BookUNIISPLATC C03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11317228690110 BLISTER PACK in 1 CARTON (31722-869-01) / 10 TABLET in 1 BLISTER PACK
- ndc11317228690210 BLISTER PACK in 1 CARTON (31722-869-02) / 10 TABLET in 1 BLISTER PACK
- ndc1131722869031 BLISTER PACK in 1 CARTON (31722-869-03) / 10 TABLET in 1 BLISTER PACK
- ndc1131722869041 BLISTER PACK in 1 CARTON (31722-869-04) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
21G72T1950
TOLVAPTAN
RxCUI 358257
Orange Book
A205646
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": "31722-869_e7e86fa1-8352-5245-e053-2995a90a70f6",
"productndc": "31722-869",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205646",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jul 16, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "15MG",
"product_no": "002",
"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": "ANDA205646",
"marketing_category": "ANDA",
"nonproprietary_name": "Tolvaptan",
"start_marketing_date": "20210716",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C03XA01.
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