Repaglinide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
258471f5-93c5-4bfc-ad43-b6a014729ab4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 29, 2023
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72162-1112
Application NumberANDA201189
Product Classification
M
Marketing Category
C73584
G
Generic Name
REPAGLINIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 29, 2023
FDA Product Classification
INGREDIENTS (11)
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
REPAGLINIDEActive
Quantity: 0.5 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT