MedPath

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

47072dcb-fe13-4aa3-849b-b7b3fbb94c51

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2011

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

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 Code66116-521
Application NumberANDA091368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2011
FDA Product Classification

INGREDIENTS (10)

CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

clonidine hydrochloride - FDA Drug Approval Details