NDC 50419-254
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 | 50419-254_12583df4-9db2-4d88-b104-bb49b28e54ff |
| NDC | 50419-254 |
| 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 | 3 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 50419-254-01
90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01)
| Marketing Start Date | 2013-10-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-254-03 [50419025403]
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 50419-254-01 [50419025401]
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 50419-254-91 [50419025491]
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 | 2.5 mg/1 |
OpenFDA Data
| SPL SET ID: | 7b57509a-3d5d-41d4-8fed-1471e26372a3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Adempas]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADEMPAS 77723142 3718134 Live/Registered |
Bayer Aktiengesellschaft 2009-04-27 |
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