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Clonidine Hydrochloride

Clonidine Hydrochloride Tablets

Approved
Approval ID

6c95c495-f630-45c1-92c3-8c0fdb22013c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 6, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-2316
Application NumberANDA202297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (9)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Clonidine Hydrochloride - FDA Drug Approval Details