Lorbrena
These highlights do not include all the information needed to use LORBRENA safely and effectively. See full prescribing information for LORBRENA. LORBRENA (lorlatinib) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
004f93d7-a1cd-4b67-9207-31cdcb5c5976
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lorlatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-927
Application NumberNDA210868
Product Classification
M
Marketing Category
C73594
G
Generic Name
lorlatinib
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (12)
LORLATINIBActive
Quantity: 25 mg in 1 1
Code: OSP71S83EU
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT