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CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE

Approved
Approval ID

4c55668e-8a40-4f07-b60f-5b74c977757b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 12, 2023

Manufacturers
FDA

DirectRX

DUNS: 079254320

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 Code61919-718
Application NumberANDA078895
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLONIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2023
FDA Product Classification

INGREDIENTS (8)

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB

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CLONIDINE HYDROCHLORIDE - FDA Drug Approval Details