FDA.reportPublic FDA data

KISQALI FEMARA CO-PACK

Product NDC
0078-0916
11-digit product format
000780916
Labeler code
0078
Product ID
0078-0916_774105bc-8258-481c-8883-f25f25166aea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole and ribociclib
Dosage form
KIT
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA209935
Marketing category
NDA
Marketing start
2017-05-04
Marketing end
2026-08-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KISQALI FEMARA CO-PACK

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui153124, 200064, 1873983, 1873989, 1923053, 1923054, 1923055, 1923056, 1923057, 1923058

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713
c68d7051-6d86-4f8e-92b8-c65801991631Product name120170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0881-50KISQALI FEMARA CO-PACK28 in 1 BOTTLE, PLASTICTABLET, FILM COATED282.5 mg25
0078-0916-61KISQALI FEMARA CO-PACK1 in 1 KITKIT125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0916-61EA - Each0078-0916eade4143-69cd-49fb-ac90-b4c2cb09814812017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0916KISQALI FEMARA CO-PACK (LETROZOLE AND RIBOCICLIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]23Current NDC, Legacy NDC, 2 package rows20250303_aa5e4446-19cd-4235-a382-5b48bf6c3b2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923054{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 21 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 200]BPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923056{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 42 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 400]BPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923058{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 63 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 600]BPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923053{28 (letrozole 2.5 MG Oral Tablet) / 21 (ribociclib 200 MG Oral Tablet) } PackGPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923055{28 (letrozole 2.5 MG Oral Tablet) / 42 (ribociclib 200 MG Oral Tablet) } PackGPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923057{28 (letrozole 2.5 MG Oral Tablet) / 63 (ribociclib 200 MG Oral Tablet) } PackGPCKaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
153124Femara 2.5 MG Oral TabletPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923054Kisqali 200 MG - Femara 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873989Kisqali 200 MG Oral TabletPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923056Kisqali 400 MG - Femara 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923058Kisqali 600 MG - Femara 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
200064letrozole 2.5 MG Oral TabletPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923053ribociclib 200 MG / letrozole 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873983ribociclib 200 MG Oral TabletPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923055ribociclib 400 MG / letrozole 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923057ribociclib 600 MG / letrozole 2.5 MG Daily Dose CartonPSNaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
153124letrozole 2.5 MG Oral Tablet [Femara]SBDaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873989ribociclib 200 MG Oral Tablet [Kisqali]SBDaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
200064letrozole 2.5 MG Oral TabletSCDaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873983ribociclib 200 MG Oral TabletSCDaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
153124Femara 2.5 MG Oral TabletSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923054Kisqali 200 MG - Femara 2.5 MG Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923054Kisqali 200 MG (21) / Femara 2.5 MG (28) Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923056Kisqali 200 MG (42) / Femara 2.5 MG (28) Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923058Kisqali 200 MG (63) / Femara 2.5 MG (28) Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873989Kisqali 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral TabletSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873989Kisqali 200 MG Oral TabletSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923056Kisqali 400 MG - Femara 2.5 MG Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923058Kisqali 600 MG - Femara 2.5 MG Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923053letrozole 2.5 MG (28) / ribociclib 200 MG (21) PackSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923055letrozole 2.5 MG (28) / ribociclib 200 MG (42) PackSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923057letrozole 2.5 MG (28) / ribociclib 200 MG (63) PackSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1923057letrozole 2.5 MG / ribociclib 600 MG Daily Dose CartonSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25
1873983ribociclib 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral TabletSYaa5e4446-19cd-4235-a382-5b48bf6c3b2f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0881-500007808815028 in 1 BOTTLE, PLASTICHistorical
0078-0916-61000780916611 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14) 1 kit2017-05-042026-08-31NoNoCurrent