Clonidine

Product NDC: 51862-454
Requested package NDC: 51862-454-04
11-digit product format: 518620454
Labeler code: 51862
Product ID: 51862-454_d876b634-0405-4ace-b85d-27191bb0b1fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLONIDINE
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Mayne Pharma Inc.
Application: ANDA079090
Marketing category: ANDA
Marketing start: 2016-08-03
Marketing end: 0000-00-00
Substance: CLONIDINE
Active strength: 0 mg/24h
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51862-454	51862-454-04	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-454	51862-454-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-454	51862-454-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079090-001	CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20
A079090-002	CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20
A079090-003	CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A079090-001	AB
A079090-002	AB
A079090-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079090-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-08-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079090-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079090-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079090-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079090-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079090-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079090-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079090-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079090-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079090-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079090-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079090-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079090-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079090-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079090-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079090-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079090-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079090-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079090-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079090-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079090-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079090-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45c8ba14-e378-46f0-b21f-1aad8e08c613	Product name	1	20250221
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	9	20190618
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	5	20171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789	Product name	2	20150123
624cf764-e200-44b5-83c2-84526255adb5	Product name	1	20150107
47972e1b-c905-eeee-5e77-eb4538ad833c	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51862-454-01	Clonidine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	11
51862-454-01	Clonidine	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	11
51862-454-04	Clonidine	4 in 1 CARTON	PATCH, EXTENDED RELEASE	4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-454-01	EA - Each	51862-454	f6b83f9b-9f41-4d6a-a8c2-efd24529ee05	1	2016-11-08
51862-454-04	EA - Each	51862-454	81c66fd9-52c6-4e9f-9c37-ce2d0caa649e	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-454	CLONIDINE PATCH, EXTENDED RELEASE [MAYNE PHARMA INC.]	9	Legacy NDC, 3 package rows	20250516_c41eb913-5e47-46c4-9d96-9a67f8380919.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine	CLONIDINE	Mayne Pharma Inc.	c41eb913-5e47-46c4-9d96-9a67f8380919	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079090 application number: ANDA079090 ndc (package): 51862-454-04 ndc (product): 51862-454 ndc11 (package): 51862045404
Clonidine	CLONIDINE	Dr. Reddy's Labratories Inc.	a179570b-eef1-176a-820c-5f603d222a60	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079090 application number: ANDA079090

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MN3L5RMN02	CLONIDINE	4205-90-7	CLONIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998671	cloNIDine HCl 0.1 MG/Day Weekly Transdermal System	PSN	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998675	cloNIDine HCl 0.2 MG/Day Weekly Transdermal System	PSN	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998679	cloNIDine HCl 0.3 MG/Day Weekly Transdermal System	PSN	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998671	168 HR clonidine 0.00417 MG/HR Transdermal System	SCD	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998675	168 HR clonidine 0.00833 MG/HR Transdermal System	SCD	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998679	168 HR clonidine 0.0125 MG/HR Transdermal System	SCD	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998671	clonidine HCl 0.1 MG/Day Weekly Transdermal System	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998675	clonidine HCl 0.2 MG/Day Weekly Transdermal System	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998679	clonidine HCl 0.3 MG/Day Weekly Transdermal System	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998671	clonidine hydrochloride 0.1 MG/Day Weekly Transdermal Patch	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998675	clonidine hydrochloride 0.2 MG/Day Weekly Transdermal Patch	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11
998679	clonidine hydrochloride 0.3 MG/Day Weekly Transdermal Patch	SY	c41eb913-5e47-46c4-9d96-9a67f8380919	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-454-04	51862045404	4 POUCH in 1 CARTON (51862-454-04) > 1 PATCH in 1 POUCH (51862-454-01) > 24 h in 1 PATCH	4 pouch	2016-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE Transdermal System USP	Mayne Pharma Inc. \| Corium, Inc. \| Eurofins Lancaster Laboratories, Inc	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	11