FDA.reportPublic FDA data

TRUQAP

Product NDC
0310-9501
11-digit product format
003109501
Labeler code
0310
Product ID
0310-9501_edd76d11-d12f-4042-bd30-a44c54b09580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capivasertib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA218197
Marketing category
NDA
Marketing start
2023-11-16
Substance
CAPIVASERTIB
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRUQAP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPIVASERTIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWFR23M21IE
Rxcui2669972, 2669978, 2669980, 2669982

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
02bdf99c-c013-4bc5-844a-27d2b653161fProduct name120250731
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-9501-01TRUQAP64 in 1 BOTTLETABLET, FILM COATED648
0310-9501-02TRUQAP16 in 1 BLISTER PACKTABLET, FILM COATED168
0310-9501-02TRUQAP4 in 1 CARTONTABLET, FILM COATED48
0310-9501-95TRUQAP64 in 1 BOTTLETABLET, FILM COATED648
0310-9501-96TRUQAP4 in 1 CARTONTABLET, FILM COATED48
0310-9501-96TRUQAP16 in 1 BLISTER PACKTABLET, FILM COATED168

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-9501-01EA - Each0310-95015688159b-80d6-4393-912a-87f74b2711e012023-12-05
0310-9501-02EA - Each0310-950104addd51-d755-4e87-9b2f-5df0f8b9885812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-9501TRUQAP (CAPIVASERTIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]7Current NDC, 6 package rows20250226_d698c106-2322-401e-b738-cbd83c843ecf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0310-9501-010031095010164 TABLET, FILM COATED in 1 BOTTLE (0310-9501-01) 2023-11-16NoNoCurrent
0310-9501-02003109501024 BLISTER PACK in 1 CARTON (0310-9501-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2024-10-18NoNoCurrent
0310-9501-950031095019564 in 1 BOTTLEHistorical
0310-9501-96003109501964 BLISTER PACK in 1 CARTON (0310-9501-96) / 16 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2024-10-23YesNoCurrent