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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

NDC Product Code62332-056
Application NumberANDA091368
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2021
Generic NameClonidine Hydrochloride

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

NDC Product Code62332-055
Application NumberANDA091368
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2021
Generic NameClonidine Hydrochloride

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

NDC Product Code62332-054
Application NumberANDA091368
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2021
Generic NameClonidine Hydrochloride

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
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clonidine hydrochloride - FDA Approval | MedPath