Nateglinide
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
c678b772-acba-4b59-a0b2-d70d84283425
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2022
Manufacturers
FDA
Cadila Pharmaceuticals Limited
DUNS: 862257719
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 Code71209-030
Application NumberANDA206432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (14)
NATEGLINIDEActive
Quantity: 60 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Nateglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-031
Application NumberANDA206432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (15)
NATEGLINIDEActive
Quantity: 120 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT