Repaglinide
These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS.REPAGLINIDE tablets, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
457c2638-86cd-4afc-b562-eea925e9d42a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 2
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 Code57664-745
Application NumberANDA077571
Product Classification
M
Marketing Category
C73584
G
Generic Name
Repaglinide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2020
FDA Product Classification
INGREDIENTS (11)
REPAGLINIDEActive
Quantity: 1 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLOXAMER 181Inactive
Code: 09Y8E6164A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Repaglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-747
Application NumberANDA077571
Product Classification
M
Marketing Category
C73584
G
Generic Name
Repaglinide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2020
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
REPAGLINIDEActive
Quantity: 2 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLOXAMER 181Inactive
Code: 09Y8E6164A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT