n, go to www.alunbrig.com or call 1-844-217-6468.CLOSE
PRINCIPAL DISPLAY PANEL - 30 MG TABLET BOTTLE LABEL
NDC 76189-113-18
Alunbrig™
(brigatinib) tablets
30 mg
Rx Only
Each tablet contains 30 mg brigatinib
180 Tablets
ARIAD®
PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
ALUNBRIG
brigatinib tablet, coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76189-113
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Brigatinib (UNII: HYW8DB273J) (Brigatinib - UNII:HYW8DB273J) Brigatinib 30 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
Color WHITE Score no score
Shape OVAL Size 7mm
Flavor Imprint Code U3
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76189-113-21 21 in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2017
2 NDC:76189-113-18 180 in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2017
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208772 04/28/2017
LABELER - ARIAD PHARMACEUTICALS INC. (786227231)
REGISTRANT - PENN PHARMACEUTICAL SERVICES LTD (226277259)
ESTABLISHMENT
Name Address ID/FEI Business Operations
ARIAD Pharmaceuticals Inc. 786227231 MANUFACTURE(76189-113) , ANALYSIS(76189-113) , PACK(76189-113) |
