Clonidine Hydrochloride
Clonidine Hydrochloride Tablets, USP
Approved
Approval ID
b4733c99-656d-4049-9422-3732492dd6ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 2
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 Code60687-113
Application NumberANDA070974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Clonidine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-124
Application NumberANDA070975
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB