Clonidine

Product NDC: 0378-0871
11-digit product format: 003780871
Labeler code: 0378
Product ID: 0378-0871_9979db75-b038-418e-b527-724d23c65932
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076166
Marketing category: ANDA
Marketing start: 2013-02-25
Substance: CLONIDINE
Active strength: .1 mg/d
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-002	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-003	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076166-001	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	2010-07-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076166-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076166-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076166-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE	.1 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MN3L5RMN02	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998671	Internal RxNorm lookup
998675	Internal RxNorm lookup
998679	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7adfc439-e6d0-4593-87dd-0eef36d33c6d	Available on FDA.report

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
0378-0871-16	Clonidine	1 in 1 POUCH	PATCH	1	12
0378-0871-16	Clonidine	7 d in 1 PATCH	PATCH	7	12
0378-0871-99	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
0378-0871-16	EA - Each	0378-0871	3594e011-4c72-46fe-bcdd-c2dc43b93c73	1	2015-05-05
0378-0871-99	EA - Each	0378-0871	18d8d8eb-83ea-4456-9573-c8d0b596818f	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
0378-0871	CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 3 package rows	20230421_7adfc439-e6d0-4593-87dd-0eef36d33c6d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine	CLONIDINE	Mylan Pharmaceuticals Inc.	7adfc439-e6d0-4593-87dd-0eef36d33c6d	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076166 application number: ANDA076166 ndc (product): 0378-0871

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
0378-0871-16	00378087116	1 in 1 POUCH						Historical
0378-0871-99	00378087199	4 POUCH in 1 CARTON (0378-0871-99) / 1 PATCH in 1 POUCH (0378-0871-16) / 7 d in 1 PATCH	4 pouch	2013-02-25	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.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	13