Clonidine
These highlights do not include all the information needed to use CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS.CLONIDINE HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1974
Approved
Approval ID
99485427-a120-4fc7-bb61-25857d1900ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-247
Application NumberANDA209675
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2020
FDA Product Classification
INGREDIENTS (8)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT