NDC 0078-0698
RYDAPT
Rydapt
RYDAPT is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Midostaurin.
| Product ID | 0078-0698_259ff0ac-725c-4f95-8616-e2285b6a5bc9 |
| NDC | 0078-0698 |
| Product Type | Human Prescription Drug |
| Proprietary Name | RYDAPT |
| Generic Name | Rydapt |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-04-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA207997 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | MIDOSTAURIN |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0078-0698-19
4 CARTON in 1 CARTON (0078-0698-19) > 14 BLISTER PACK in 1 CARTON (0078-0698-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)
| Marketing Start Date | 2017-04-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0078-0698-02 [00078069802]
RYDAPT CAPSULE, LIQUID FILLED
| Marketing Category | NDA |
| Application Number | NDA207997 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-04-28 |
NDC 0078-0698-99 [00078069899]
RYDAPT CAPSULE, LIQUID FILLED
| Marketing Category | NDA |
| Application Number | NDA207997 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-04-28 |
NDC 0078-0698-51 [00078069851]
RYDAPT CAPSULE, LIQUID FILLED
| Marketing Category | NDA |
| Application Number | NDA207997 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-04-28 |
NDC 0078-0698-19 [00078069819]
RYDAPT CAPSULE, LIQUID FILLED
| Marketing Category | NDA |
| Application Number | NDA207997 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-04-28 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MIDOSTAURIN | 25 mg/1 |
OpenFDA Data
| SPL SET ID: | 11fa3fc9-6776-49a6-b1c1-653f627c3e58 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Receptor Tyrosine Kinase Inhibitors [MoA]
Trademark Results [RYDAPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RYDAPT 79149774 4710118 Live/Registered |
Novartis AG 2014-06-04 |
 RYDAPT 79043585 3441082 Dead/Cancelled |
Novartis AG 2007-08-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.