Nateglinide
NATEGLINIDE TABLETS. These highlights do not include all the information needed to use NATEGLINIDE TABLETS safely and effectively. See full prescribing information for NATEGLINIDE TABLETS. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
e920b343-f53e-7487-e053-2995a90a719a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2022
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-656
Application NumberANDA077463
Product Classification
M
Marketing Category
C73584
G
Generic Name
nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2022
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NATEGLINIDEActive
Quantity: 60 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
nateglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-657
Application NumberANDA077463
Product Classification
M
Marketing Category
C73584
G
Generic Name
nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2022
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NATEGLINIDEActive
Quantity: 120 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT