DAPIPRAZOLE

Product NDC
53020-265
11-digit product format
530200265
Labeler code
53020
Product ID
53020-265_14ba15fc-b733-44b1-a3ef-161654292782
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPIPRAZOLE
Dosage form
KIT
Labeler
Baradaina, LLC
Application
ANDA204902
Marketing category
ANDA
Marketing start
2019-07-31
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0a77f84f-9f13-4f19-a57a-ce66f11752cbProduct name120190828
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53020-255-01DAPIPRAZOLE5 mL in 1 VIALPOWDER, FOR SOLUTION5 mL25 mg in 5mL3
53020-265-01DAPIPRAZOLE1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53020-265DAPIPRAZOLE KIT [BARADAINA, LLC]3Legacy NDC, 2 package rows20240110_8b0fde24-9549-11cf-e053-2a95a90a9338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309649dapiprazole HCl 0.5 % Ophthalmic SolutionPSN8b0fde24-9549-11cf-e053-2a95a90a93383
309649dapiprazole 5 MG/ML Ophthalmic SolutionSCD8b0fde24-9549-11cf-e053-2a95a90a93383
309649dapiprazole 0.5 % Ophthalmic SolutionSY8b0fde24-9549-11cf-e053-2a95a90a93383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53020-255-01530200255015 mL in 1 VIAL5 mlHistorical
53020-265-01530200265011 KIT in 1 CARTON (53020-265-01) * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01) 1 kit2019-07-310000-00-00NoNoCurrent