FDA.reportPublic FDA data

Alunbrig

Product NDC
63020-113
11-digit product format
630200113
Labeler code
63020
Product ID
63020-113_176eb255-05c0-4cfc-874f-1fb57136d34d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brigatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA208772
Marketing category
NDA
Marketing start
2017-04-28
Substance
BRIGATINIB
Active strength
30 mg/1
Pharmacologic classes
Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase 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
Alunbrig
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIGATINIB30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHYW8DB273J
Rxcui1921222, 1921228, 1925494, 1988768, 1988770, 1988772, 1988785, 1988786

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7e54a2c5-e3f2-4273-8a10-321aacfdbb07Product name220201030

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63020-113-302025-08-18C16284748780-13b156c62-273c-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017
63020-113-302025-07-29C16284748780-13b156c62-273c-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63020-113-30Alunbrig30 in 1 BOTTLETABLET, FILM COATED3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63020-113-30EA - Each63020-11320079e9e-fbd5-4608-9120-216b11098b9512018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63020-113ALUNBRIG (BRIGATINIB) TABLET, FILM COATED ALUNBRIG (BRIGATINIB) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]15Current NDC, Legacy NDC, 1 package rows20241030_0fe9ff20-d402-41f3-bc1e-7002ea7007db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1988786{23 (brigatinib 180 MG Oral Tablet [Alunbrig]) / 7 (brigatinib 90 MG Oral Tablet [Alunbrig]) } Pack [Alunbrig Initiation Pack]BPCK0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988785{23 (brigatinib 180 MG Oral Tablet) / 7 (brigatinib 90 MG Oral Tablet) } PackGPCK0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988772ALUNBRIG 180 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1921228ALUNBRIG 30 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988768ALUNBRIG 90 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988786ALUNBRIG Initiation PackPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988770brigatinib 180 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988785brigatinib 180 MG Oral Tablet (23) / brigatinib 90 MG Oral Tablet (7) PackPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1921222brigatinib 30 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1925494brigatinib 90 MG Oral TabletPSN0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988772brigatinib 180 MG Oral Tablet [Alunbrig]SBD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1921228brigatinib 30 MG Oral Tablet [Alunbrig]SBD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988768brigatinib 90 MG Oral Tablet [Alunbrig]SBD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988770brigatinib 180 MG Oral TabletSCD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1921222brigatinib 30 MG Oral TabletSCD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1925494brigatinib 90 MG Oral TabletSCD0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988772Alunbrig 180 MG Oral TabletSY0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1921228Alunbrig 30 MG Oral TabletSY0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988768Alunbrig 90 MG Oral TabletSY0fe9ff20-d402-41f3-bc1e-7002ea7007db17
1988786Alunbrig Initiation PackSY0fe9ff20-d402-41f3-bc1e-7002ea7007db17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63020-113-1863020011318180 TABLET, FILM COATED in 1 BOTTLE (63020-113-18) 2017-10-020000-00-00NoNoCurrent
63020-113-216302001132121 TABLET, FILM COATED in 1 BOTTLE (63020-113-21) 2017-10-020000-00-00NoNoCurrent
63020-113-306302001133030 TABLET, FILM COATED in 1 BOTTLE (63020-113-30) 2017-10-020000-00-00NoNoCurrent