Nateglinide
Nateglinide tablet, coated
Approved
Approval ID
494ad835-1aec-469a-bf84-3f32a68796ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2023
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
NDC Product Code60429-435
Application NumberANDA077463
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 14, 2023
Generic NameNateglinide
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NATEGLINIDEActive
Quantity: 120 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
Nateglinide
PRODUCT DETAILS
NDC Product Code60429-434
Application NumberANDA077463
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 14, 2023
Generic NameNateglinide
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NATEGLINIDEActive
Quantity: 60 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT