NDC 50419-171
Stivarga
Regorafenib
Stivarga 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 Regorafenib Monohydrate.
| Product ID | 50419-171_39f424e8-6b78-4a30-b19f-de42dc208856 |
| NDC | 50419-171 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Stivarga |
| Generic Name | Regorafenib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-09-27 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203085 |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | REGORAFENIB MONOHYDRATE |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 50419-171-00
210 BOTTLE in 1 BOX (50419-171-00) > 28 TABLET, FILM COATED in 1 BOTTLE
| Marketing Start Date | 2012-09-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-171-01 [50419017101]
Stivarga TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203085 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-09-27 |
NDC 50419-171-03 [50419017103]
Stivarga TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203085 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-09-27 |
NDC 50419-171-00 [50419017100]
Stivarga TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203085 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-09-27 |
NDC 50419-171-04 [50419017104]
Stivarga TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203085 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-09-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| REGORAFENIB MONOHYDRATE | 40 mg/1 |
OpenFDA Data
| SPL SET ID: | 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
- Cytochrome P450 2C9 Inhibitors [MoA]
Trademark Results [Stivarga]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIVARGA 85392954 4111942 Live/Registered |
Bayer Aktiengesellschaft 2011-08-09 |
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