adempas

Generic: riociguat

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name adempas
Generic Name riociguat
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

riociguat 2.5 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-254
Product ID 50419-254_401e09f1-da30-4f84-9f47-a788f0b46576
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204819
Listing Expiration 2027-12-31
Marketing Start 2013-10-08

Pharmacologic Class

Established (EPC)
soluble guanylate cyclase stimulator [epc]
Mechanism of Action
guanylate cyclase stimulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419254
Hyphenated Format 50419-254

Supplemental Identifiers

RxCUI
1439821 1439823 1439831 1439833 1439837 1439894 1439896 1439899 1439901 1439903
UNII
RU3FE2Y4XI
NUI
N0000190484 N0000190485

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name adempas (source: ndc)
Generic Name riociguat (source: ndc)
Application Number NDA204819 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01)
  • 2 BLISTER PACK in 1 PACKAGE (50419-254-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK
  • 9 TABLET, FILM COATED in 1 BOTTLE (50419-254-91)
source: ndc

Packages (3)

50419-254-01 90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01) 50419-254-03 2 BLISTER PACK in 1 PACKAGE (50419-254-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK 50419-254-91 9 TABLET, FILM COATED in 1 BOTTLE (50419-254-91)

Ingredients (1)

riociguat (2.5 mg/1)

Linked Drug Pages (1)

Adempas ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "401e09f1-da30-4f84-9f47-a788f0b46576", "openfda": {"nui": ["N0000190484", "N0000190485"], "unii": ["RU3FE2Y4XI"], "rxcui": ["1439821", "1439823", "1439831", "1439833", "1439837", "1439894", "1439896", "1439899", "1439901", "1439903"], "spl_set_id": ["7b57509a-3d5d-41d4-8fed-1471e26372a3"], "pharm_class_epc": ["Soluble Guanylate Cyclase Stimulator [EPC]"], "pharm_class_moa": ["Guanylate Cyclase Stimulators [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01)", "package_ndc": "50419-254-01", "marketing_start_date": "20131008"}, {"sample": false, "description": "2 BLISTER PACK in 1 PACKAGE (50419-254-03)  / 21 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50419-254-03", "marketing_start_date": "20131008"}, {"sample": false, "description": "9 TABLET, FILM COATED in 1 BOTTLE (50419-254-91)", "package_ndc": "50419-254-91", "marketing_start_date": "20140918"}], "brand_name": "Adempas", "product_id": "50419-254_401e09f1-da30-4f84-9f47-a788f0b46576", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Guanylate Cyclase Stimulators [MoA]", "Soluble Guanylate Cyclase Stimulator [EPC]"], "product_ndc": "50419-254", "generic_name": "riociguat", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adempas", "active_ingredients": [{"name": "RIOCIGUAT", "strength": "2.5 mg/1"}], "application_number": "NDA204819", "marketing_category": "NDA", "marketing_start_date": "20131008", "listing_expiration_date": "20271231"}