Clonidine
CLONIDINE EXTENDED-RELEASE TABLETS These highlights do not include all the information needed to use CLONIDINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLONIDINE EXTENDED-RELEASE TABLETS. CLONIDINE Extended-Release Tablets, for oral use Initial U.S. Approval: 1974
Approved
Approval ID
e93324f1-ad83-7bbe-e053-2995a90a8c9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
PALMETTO PHARMACEUTICALS INC.
DUNS: 963291864
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clonidine
PRODUCT DETAILS
NDC Product Code68134-603
Application NumberNDA022500
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateJanuary 11, 2024
Generic NameClonidine
INGREDIENTS (13)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM SILICATEInactive
Code: IJF18F77L3
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
CLONIDINEActive
Quantity: 0.17 mg in 1 1
Code: MN3L5RMN02
Classification: ACTIB