Repaglinide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .REPAGLINIDE tablets, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
7f10bf63-06c8-477d-a13e-fb88e287617a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
REPAGLINIDE
PRODUCT DETAILS
NDC Product Code63629-9194
Application NumberANDA201189
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 15, 2024
Generic NameREPAGLINIDE
INGREDIENTS (12)
REPAGLINIDEActive
Quantity: 2 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT