Nateglinide
These highlights do not include all the information needed to use NATEGLINIDE TABELTS safely and effectively. See full prescribing information for NATEGLINIDE TABELTS. NATEGLINIDE tablets, for oral useInitial U.S. Approval: 2000
Approved
Approval ID
88698921-cd8f-4d41-96e6-ff671913c5c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nateglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-722
Application NumberANDA205248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (15)
NATEGLINIDEActive
Quantity: 120 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Nateglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-721
Application NumberANDA205248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (13)
NATEGLINIDEActive
Quantity: 60 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT