clonidine hydrochloride
Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
Approved
Approval ID
61b56917-1442-4068-86d8-0e5a5a59e612
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 3
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 Code62332-056
Application NumberANDA091368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.3 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
Clonidine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-055
Application NumberANDA091368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (8)
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Clonidine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-054
Application NumberANDA091368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT