NDC 50419-252

Adempas

Riociguat

Adempas is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Riociguat.

• Product ID: 50419-252_12583df4-9db2-4d88-b104-bb49b28e54ff
• NDC: 50419-252
• Product Type: Human Prescription Drug
• Proprietary Name: Adempas
• Generic Name: Riociguat
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-10-08
• Marketing Category: NDA / NDA
• Application Number: NDA204819
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: RIOCIGUAT
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50419-252-01

90 TABLET, FILM COATED in 1 BOTTLE (50419-252-01)

• Marketing Start Date: 2013-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-252-03 [50419025203]

Adempas TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-10-08

NDC 50419-252-01 [50419025201]

Adempas TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-08

NDC 50419-252-91 [50419025291]

Adempas TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-18

Drug Details

Active Ingredients

Ingredient	Strength
RIOCIGUAT	1.5 mg/1

OpenFDA Data

• SPL SET ID: 7b57509a-3d5d-41d4-8fed-1471e26372a3
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • RU3FE2Y4XI
• RxNorm Concept Unique ID - RxCUI:
  • 1439894
  • 1439896
  • 1439899
  • 1439903
  • 1439901
  • 1439837
  • 1439833
  • 1439821
  • 1439831
  • 1439823

Pharmacological Class

• Guanylate Cyclase Stimulators [MoA]
• Soluble Guanylate Cyclase Stimulator [EPC]

NDC Crossover Matching brand name "Adempas" or generic name "Riociguat"

NDC	Brand Name	Generic Name
50419-250	Adempas	riociguat
50419-251	Adempas	riociguat
50419-252	Adempas	riociguat
50419-253	Adempas	riociguat
50419-254	Adempas	riociguat