Nateglinide
Approved
Approval ID
b1cc7bfa-532b-45b0-92bf-18a83271166b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6255
Application NumberANDA077463
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nateglinide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2011
FDA Product Classification
INGREDIENTS (8)
NATEGLINIDEActive
Quantity: 120 mg in 1 1
Code: 41X3PWK4O2
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT