Clonidine Transdermal System USP, 0.3 mg/day

Overview

Brand name

Clonidine Transdermal System USP, 0.3 mg/day

Generic name

clonidine transdermal system

Dosage form

Patch

Route

Transdermal

Marketing category

NDA AUTHORIZED GENERIC · NDA AG

Labeler

TruPharma, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Clonidine	.3 mg/d	998671	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Patch

Route of administration

Transdermal

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Adrenergic alpha2-Agonists [MoA]	MoA	All 44 members
Central alpha-2 Adrenergic Agonist [EPC]	EPC	All 44 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

018891

Application type

NDA · New Drug Application

Approval date

October 10, 1984

Sponsor

LAVIPHARM

Products on application

3

Submissions recorded

29

Products approved under application 018891.
Product	Trade name	Form	Ingredient	Status	TE	Flags
018891-001	CATAPRES-TTS-1	SYSTEM	CLONIDINE	Prescription	AB	RLD
018891-002	CATAPRES-TTS-2	SYSTEM	CLONIDINE	Prescription	AB	RLD
018891-003	CATAPRES-TTS-3	SYSTEM	CLONIDINE	Prescription	AB	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

Yes

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 018891.
Type	No.	Action	Status	Date	Review
Supplement	34	Manufacturing (CMC)	Approved	December 4, 2025	N/A
Supplement	32	Labeling	Approved	February 1, 2023	Standard
Supplement	28	Labeling	Approved	May 31, 2012	Unknown
Supplement	27	Labeling	Approved	April 28, 2010	Unknown
Supplement	25	Labeling	Approved	November 13, 2009	Standard
Supplement	24	Labeling	Approved	April 13, 2006	Standard
Supplement	22	Labeling	Approved	August 13, 2004	Standard
Supplement	21	Manufacturing (CMC)	Approved	August 30, 1999	Standard
Supplement	20	Manufacturing (CMC)	Approved	September 22, 1998	Standard
Supplement	19	Manufacturing (CMC)	Approved	October 3, 1997	Standard
Supplement	16	Labeling	Approved	September 6, 1996	Standard
Supplement	15	Labeling	Approved	September 6, 1996	Standard
Supplement	18	Manufacturing (CMC)	Approved	July 23, 1996	Standard
Supplement	17	Manufacturing (CMC)	Approved	July 23, 1996	Standard
Supplement	10	Manufacturing (CMC)	Approved	June 9, 1995	Standard
Supplement	14	Manufacturing (CMC)	Approved	February 19, 1993	Standard
Supplement	13	Manufacturing (CMC)	Approved	November 24, 1992	Standard
Supplement	12	Manufacturing (CMC)	Approved	August 17, 1992	Standard
Supplement	11	Manufacturing (CMC)	Approved	December 13, 1989	Standard
Supplement	9	Labeling	Approved	April 18, 1989	—
Supplement	8	Labeling	Approved	December 7, 1988	—
Supplement	7	Manufacturing (CMC)	Approved	October 27, 1988	Standard
Supplement	6	Manufacturing (CMC)	Approved	July 21, 1988	Standard
Supplement	4	Labeling	Approved	May 11, 1988	—
Supplement	3	Labeling	Approved	May 11, 1988	—
Supplement	5	Manufacturing (CMC)	Approved	October 14, 1987	Standard
Supplement	2	Labeling	Approved	September 18, 1985	—
Supplement	1	Labeling	Approved	April 18, 1985	—
Original application	1	Type 3 - New Dosage Form	Approved	October 10, 1984	Standard

Review documents

0 · Supplement · June 23, 2026
0 · Supplement · June 23, 2026
0 · Supplement · February 6, 2023
0 · Supplement · February 3, 2023
0 · Supplement · February 2, 2023
0 · Supplement · June 7, 2012
0 · Supplement · June 6, 2012
0 · Supplement · May 7, 2010
0 · Supplement · May 3, 2010
0 · Supplement · January 7, 2010
0 · Supplement · November 13, 2009
0 · Supplement · April 14, 2006
0 · Supplement · August 25, 2004
0 · Supplement · August 5, 2003

Adverse event reports

Source: openFDA FAERS

57,113

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CLONIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
52817-507-04	52817-507	TruPharma, LLC	4 POUCH in 1 CARTON (52817-507-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	March 30, 2026
52817-612-04	52817-612	TruPharma, LLC	4 POUCH in 1 CARTON (52817-612-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	June 30, 2023
52817-507	52817-507	TruPharma, LLC	—	March 30, 2026
52817-612	52817-612	TruPharma, LLC	—	June 30, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.