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Clonidine Transdermal System USP, 0.1 mg/day

Clonidine Transdermal System USP, 0.1 mg/day Clonidine Transdermal System USP, 0.2 mg/day Clonidine Transdermal System USP, 0.3 mg/day

Approved
Approval ID

05d520bf-3ab7-4337-9f38-4418e5e7e1e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 30, 2023

Manufacturers
FDA

TruPharma, LLC

DUNS: 078533947

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

clonidine transdermal system

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-612
Application NumberNDA018891
Product Classification
M
Marketing Category
C73605
G
Generic Name
clonidine transdermal system
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 30, 2023
FDA Product Classification

INGREDIENTS (5)

CLONIDINEActive
Quantity: 0.3 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
POLYISOBUTYLENE (35000 MW)Inactive
Code: 98553S1MHQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT

clonidine transdermal system

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-610
Application NumberNDA018891
Product Classification
M
Marketing Category
C73605
G
Generic Name
clonidine transdermal system
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 30, 2023
FDA Product Classification

INGREDIENTS (5)

CLONIDINEActive
Quantity: 0.1 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
POLYISOBUTYLENE (35000 MW)Inactive
Code: 98553S1MHQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

clonidine transdermal system

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-611
Application NumberNDA018891
Product Classification
M
Marketing Category
C73605
G
Generic Name
clonidine transdermal system
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 30, 2023
FDA Product Classification

INGREDIENTS (5)

CLONIDINEActive
Quantity: 0.2 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYISOBUTYLENE (35000 MW)Inactive
Code: 98553S1MHQ
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/17/2025

STORAGE AND HANDLING

Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Distributed by:

TruPharma LLC,
Tampa FL 33609, USA

Address medical inquiries to: (877) 541-5504

Revised: March 2023

222078

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Clonidine Transdermal System USP, 0.1 mg/day - FDA Drug Approval Details