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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68134-603
Application NumberNDA022500
Product Classification
M
Marketing Category
C73605
G
Generic Name
Clonidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2024
FDA Product Classification
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