alunbrig

Generic: brigatinib

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name alunbrig
Generic Name brigatinib
Labeler takeda pharmaceuticals america, inc.
Dosage Form KIT
Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 63020-198
Product ID 63020-198_176eb255-05c0-4cfc-874f-1fb57136d34d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208772
Listing Expiration 2027-12-31
Marketing Start 2017-04-28

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
tyrosine kinase inhibitors [moa] cytochrome p450 3a inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63020198
Hyphenated Format 63020-198

Supplemental Identifiers

RxCUI
1921222 1921228 1925494 1988768 1988770 1988772 1988785 1988786
UNII
HYW8DB273J
NUI
N0000175605 N0000020001 N0000190118

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alunbrig (source: ndc)
Generic Name brigatinib (source: ndc)
Application Number NDA208772 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 180 mg
  • 90 mg
  • 30 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (63020-198-30) * 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) * 23 TABLET, FILM COATED in 1 BOTTLE (63020-180-23)
source: ndc

Packages (1)

63020-198-30 1 KIT in 1 CARTON (63020-198-30) * 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) * 23 TABLET, FILM COATED in 1 BOTTLE (63020-180-23)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Alunbrig ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "176eb255-05c0-4cfc-874f-1fb57136d34d", "openfda": {"nui": ["N0000175605", "N0000020001", "N0000190118"], "unii": ["HYW8DB273J"], "rxcui": ["1921222", "1921228", "1925494", "1988768", "1988770", "1988772", "1988785", "1988786"], "spl_set_id": ["0fe9ff20-d402-41f3-bc1e-7002ea7007db"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (63020-198-30)  *  7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07)  *  23 TABLET, FILM COATED in 1 BOTTLE (63020-180-23)", "package_ndc": "63020-198-30", "marketing_start_date": "20171002"}], "brand_name": "Alunbrig", "product_id": "63020-198_176eb255-05c0-4cfc-874f-1fb57136d34d", "dosage_form": "KIT", "product_ndc": "63020-198", "generic_name": "brigatinib", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alunbrig", "application_number": "NDA208772", "marketing_category": "NDA", "marketing_start_date": "20170428", "listing_expiration_date": "20271231"}