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United States · US · US:50419-254_4919c19b-7cbb-4724-a711-7f908b7d18e7
Adempas
Orange BookUNIISPLATC C02KX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC02KX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11504192540190 TABLET, FILM COATED in 1 BOTTLE (50419-254-01)
- ndc1150419254032 BLISTER PACK in 1 PACKAGE (50419-254-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1150419254919 TABLET, FILM COATED in 1 BOTTLE (50419-254-91)
Annotations
UNII (FDA Substance ID)
RU3FE2Y4XI
RIOCIGUAT
RxCUI 1439816
Orange Book
N204819
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RU3FE2Y4XI",
"rxcui": "1439816",
"inchikey": "WXXSNCNJFUAIDG-UHFFFAOYSA-N",
"display_name": "RIOCIGUAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7b57509a-3d5d-41d4-8fed-1471e26372a3": {
"match": "brand_token",
"title": "ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "29",
"published_date": "2026-04-13"
}
},
"productid": "50419-254_4919c19b-7cbb-4724-a711-7f908b7d18e7",
"productndc": "50419-254",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204819",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Oct 8, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Oct 8, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "1.5MG",
"product_no": "003",
"approval_date": "Oct 8, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "004",
"approval_date": "Oct 8, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "005",
"approval_date": "Oct 8, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIOCIGUAT",
"proprietary_name": "Adempas",
"active_ingred_unit": "mg/1",
"application_number": "NDA204819",
"marketing_category": "NDA",
"nonproprietary_name": "riociguat",
"start_marketing_date": "20131008",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C02KX05.
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