FDA.reportPublic FDA data

RYDAPT

Product NDC
0078-0698
11-digit product format
000780698
Labeler code
0078
Product ID
0078-0698_8903ad5f-436d-46ae-9f34-8415cbb8d993
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RYDAPT
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA207997
Marketing category
NDA
Marketing start
2017-04-28
Substance
MIDOSTAURIN
Active strength
25 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RYDAPT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDOSTAURIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiID912S5VON
Rxcui1919088

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
af6bd6a7-602e-408a-b789-ab1d36762e50Product name220250220
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0698-02RYDAPT2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED214
0078-0698-19RYDAPT4 in 1 CARTONCAPSULE, LIQUID FILLED414
0078-0698-51RYDAPT14 in 1 CARTONCAPSULE, LIQUID FILLED1414
0078-0698-99RYDAPT2 in 1 CARTONCAPSULE, LIQUID FILLED214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0698-02EA - Each0078-069817d47c96-6d3e-434c-9aa8-365d823de28c12017-06-15
0078-0698-19EA - Each0078-069823be29f6-5ac0-4c04-b6d3-88ee8bf2763a12017-06-15
0078-0698-51EA - Each0078-0698de5bfbd5-d4a8-4f1a-8b23-8b367530128a12017-06-15
0078-0698-99EA - Each0078-069897eb6be6-be42-42ac-b2bd-9b4790f2621a12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0698RYDAPT CAPSULE, LIQUID FILLED [NOVARTIS PHARMACEUTICALS CORPORATION]13Current NDC, Legacy NDC, 4 package rows20240724_11fa3fc9-6776-49a6-b1c1-653f627c3e58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1919088midostaurin 25 MG Oral CapsulePSN11fa3fc9-6776-49a6-b1c1-653f627c3e5814
1919088midostaurin 25 MG Oral CapsuleSCD11fa3fc9-6776-49a6-b1c1-653f627c3e5814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0698-02000780698022 in 1 BLISTER PACKHistorical
0078-0698-19000780698194 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) 4 carton2017-04-280000-00-00NoNoCurrent
0078-0698-510007806985114 in 1 CARTONHistorical
0078-0698-99000780698992 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) 2 carton2017-04-280000-00-00NoNoCurrent