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clonidine hydrochloride

Clonidine Hydrochloride Tablets, USP

Approved
Approval ID

22fbd302-46b5-4bdc-87e2-fda94cb22530

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 8, 2024

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-7009
Application NumberANDA078895
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2020
FDA Product Classification

INGREDIENTS (9)

CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
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, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/8/2024

clonidine hydrochloride

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clonidine hydrochloride - FDA Drug Approval Details