FDA.reportPublic FDA data

JAYPIRCA

Product NDC
0002-7026
11-digit product format
000027026
Labeler code
0002
Product ID
0002-7026_ef421dc8-11db-4e6c-9154-dc04782cb52c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pirtobrutinib
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA216059
Marketing category
NDA
Marketing start
2023-01-27
Substance
PIRTOBRUTINIB
Active strength
100 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Bruton's Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIRTOBRUTINIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJNA39I7ZVB
Rxcui2629343, 2629349, 2629351, 2629353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2428a55d-ee72-4c52-8fe6-5cdd94d2f812Product name120240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-7026-60JAYPIRCA60 in 1 BOTTLETABLET, COATED6014
0002-7026-99JAYPIRCA30 in 1 BOTTLETABLET, COATED3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7026-60EA - Each0002-7026528a31e8-f943-434f-b1bb-895d9cbd04e912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7026JAYPIRCA (PIRTOBRUTINIB) TABLET, COATED [ELI LILLY AND COMPANY]11Current NDC, 2 package rows20250321_bd551845-0878-49a4-860f-839b83f6b801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2629349Jaypirca 100 MG Oral TabletPSNbd551845-0878-49a4-860f-839b83f6b80114
2629353Jaypirca 50 MG Oral TabletPSNbd551845-0878-49a4-860f-839b83f6b80114
2629343pirtobrutinib 100 MG Oral TabletPSNbd551845-0878-49a4-860f-839b83f6b80114
2629351pirtobrutinib 50 MG Oral TabletPSNbd551845-0878-49a4-860f-839b83f6b80114
2629349pirtobrutinib 100 MG Oral Tablet [Jaypirca]SBDbd551845-0878-49a4-860f-839b83f6b80114
2629353pirtobrutinib 50 MG Oral Tablet [Jaypirca]SBDbd551845-0878-49a4-860f-839b83f6b80114
2629343pirtobrutinib 100 MG Oral TabletSCDbd551845-0878-49a4-860f-839b83f6b80114
2629351pirtobrutinib 50 MG Oral TabletSCDbd551845-0878-49a4-860f-839b83f6b80114
2629349Jaypirca 100 MG Oral TabletSYbd551845-0878-49a4-860f-839b83f6b80114
2629353Jaypirca 50 MG Oral TabletSYbd551845-0878-49a4-860f-839b83f6b80114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0002-7026-600000270266060 TABLET, COATED in 1 BOTTLE (0002-7026-60) 2023-01-27NoNoHistorical
0002-7026-990000270269930 TABLET, COATED in 1 BOTTLE (0002-7026-99) 2023-02-15YesNoHistorical