FDA.reportPublic FDA data

ALECENSA

Product NDC
50242-130
11-digit product format
502420130
Labeler code
50242
Product ID
50242-130_abdb3f90-4a44-4404-a49c-8d3bbc4dd13b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALECTINIB HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA208434
Marketing category
NDA
Marketing start
2015-12-11
Substance
ALECTINIB HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], 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
ALECENSA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALECTINIB HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP9YY73LO6J
Rxcui1727479, 1727485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
90087b9e-cf04-431c-85fd-3675de4290dfProduct name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50242-130-012020-07-29C16284748780-1ab0e2407-2e82-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015
50242-130-862020-07-29C16284748780-1ab0e2407-2e82-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015
50242-130-012020-07-22C16284748780-1ab0e2407-2e82-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015
50242-130-862020-07-22C16284748780-1ab0e2407-2e82-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-130-01ALECENSA1 in 1 CARTONCAPSULE127
50242-130-01ALECENSA240 in 1 BOTTLE, PLASTICCAPSULE24027
50242-130-86ALECENSA1 in 1 CARTONCAPSULE127
50242-130-86ALECENSA240 in 1 BOTTLE, PLASTICCAPSULE24027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-130-01EA - Each50242-130f314644b-5262-4d80-80e9-7598920b16b512016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-130ALECENSA (ALECTINIB HYDROCHLORIDE) CAPSULE [GENENTECH, INC.]24Current NDC, Legacy NDC, 4 package rows20241127_42c49deb-713b-427a-9670-08af08adcffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1727485Alecensa 150 MG Oral CapsulePSN42c49deb-713b-427a-9670-08af08adcffb27
1727479alectinib 150 MG Oral CapsulePSN42c49deb-713b-427a-9670-08af08adcffb27
1727485alectinib 150 MG Oral Capsule [Alecensa]SBD42c49deb-713b-427a-9670-08af08adcffb27
1727479alectinib 150 MG Oral CapsuleSCD42c49deb-713b-427a-9670-08af08adcffb27
1727485Alecensa 150 MG Oral CapsuleSY42c49deb-713b-427a-9670-08af08adcffb27
1727485alectinib 150 MG (as alectinib HCl 161.33 MG) Oral Capsule [Alecensa]SY42c49deb-713b-427a-9670-08af08adcffb27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-130-01502420130011 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC2015-12-110000-00-00NoNoCurrent
50242-130-86502420130861 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC2017-10-100000-00-00YesNoCurrent