Clonidine

Product NDC: 0378-0872
11-digit product format: 003780872
Labeler code: 0378
Product ID: 0378-0872_abb0caaf-1d1c-47c1-9c16-c47656dd4124
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076166
Marketing category: ANDA
Marketing start: 2013-03-04
Substance: CLONIDINE
Active strength: .2 mg/d
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076166-001	CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16
A076166-002	CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16
A076166-003	CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076166-001	AB
A076166-002	AB
A076166-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076166-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076166-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076166-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076166-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076166-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076166-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076166-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076166-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076166-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076166-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076166-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076166-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076166-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076166-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076166-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076166-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076166-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076166-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076166-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076166-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076166-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076166-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Clonidine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE	.2 mg/d

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
0378-0872-16	Clonidine	7 d in 1 PATCH	PATCH	7	12
0378-0872-16	Clonidine	1 in 1 POUCH	PATCH	1	12
0378-0872-99	Clonidine	4 in 1 CARTON	PATCH	4	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0872-16	EA - Each	0378-0872	5f220ff5-83c1-4e4c-92db-7e95d38a28a9	1	2015-08-04
0378-0872-99	EA - Each	0378-0872	55c13269-4dbf-4df6-96dc-488792ded69c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE	ACTIVE INGREDIENT	MN3L5RMN02	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	8
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	8
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0872	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 3 package rows	20230421_7adfc439-e6d0-4593-87dd-0eef36d33c6d.zip

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	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998675	cloNIDine HCl 0.2 MG/Day Weekly Transdermal System	PSN	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998679	cloNIDine HCl 0.3 MG/Day Weekly Transdermal System	PSN	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998671	168 HR clonidine 0.00417 MG/HR Transdermal System	SCD	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998675	168 HR clonidine 0.00833 MG/HR Transdermal System	SCD	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998679	168 HR clonidine 0.0125 MG/HR Transdermal System	SCD	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998671	clonidine HCl 0.1 MG/Day Weekly Transdermal System	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998675	clonidine HCl 0.2 MG/Day Weekly Transdermal System	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998679	clonidine HCl 0.3 MG/Day Weekly Transdermal System	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998671	clonidine hydrochloride 0.1 MG/Day Weekly Transdermal Patch	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998675	clonidine hydrochloride 0.2 MG/Day Weekly Transdermal Patch	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12
998679	clonidine hydrochloride 0.3 MG/Day Weekly Transdermal Patch	SY	7adfc439-e6d0-4593-87dd-0eef36d33c6d	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0872-16	00378087216	7 d in 1 PATCH	7 d					Historical
0378-0872-99	00378087299	4 POUCH in 1 CARTON (0378-0872-99) / 1 PATCH in 1 POUCH (0378-0872-16) / 7 d in 1 PATCH	4 pouch	2013-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Transdermal System, USP 0.1 mg/day, 0.2 mg/day and 0.3mg/day	Mylan Pharmaceuticals Inc.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	14