Clonidine Hydrochloride
CLONIDINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
5fb77f20-3845-452a-8f03-8d78d800dee4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clonidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-623
Application NumberANDA077901
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2013
FDA Product Classification
INGREDIENTS (8)
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.200 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT