rydapt

Generic: rydapt

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rydapt
Generic Name rydapt
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

midostaurin 25 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0698
Product ID 0078-0698_8903ad5f-436d-46ae-9f34-8415cbb8d993
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207997
Listing Expiration 2026-12-31
Marketing Start 2017-04-28

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
receptor tyrosine kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780698
Hyphenated Format 0078-0698

Supplemental Identifiers

RxCUI
1919088
UNII
ID912S5VON
NUI
N0000175605 N0000020000

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 rydapt (source: ndc)
Generic Name rydapt (source: ndc)
Application Number NDA207997 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 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)
  • 2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)
source: ndc

Packages (2)

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) 0078-0698-99 2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)

Ingredients (1)

midostaurin (25 mg/1)

Linked Drug Pages (1)

RYDAPT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8903ad5f-436d-46ae-9f34-8415cbb8d993", "openfda": {"nui": ["N0000175605", "N0000020000"], "unii": ["ID912S5VON"], "rxcui": ["1919088"], "spl_set_id": ["11fa3fc9-6776-49a6-b1c1-653f627c3e58"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Receptor Tyrosine Kinase Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0078-0698-19", "marketing_start_date": "20170428"}, {"sample": false, "description": "2 CARTON in 1 CARTON (0078-0698-99)  / 14 BLISTER PACK in 1 CARTON (0078-0698-51)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)", "package_ndc": "0078-0698-99", "marketing_start_date": "20170428"}], "brand_name": "RYDAPT", "product_id": "0078-0698_8903ad5f-436d-46ae-9f34-8415cbb8d993", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Kinase Inhibitor [EPC]", "Receptor Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0078-0698", "generic_name": "RYDAPT", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RYDAPT", "active_ingredients": [{"name": "MIDOSTAURIN", "strength": "25 mg/1"}], "application_number": "NDA207997", "marketing_category": "NDA", "marketing_start_date": "20170428", "listing_expiration_date": "20261231"}