Clonidine Hydrochloride

Product NDC: 0228-4241
11-digit product format: 002284241
Labeler code: 0228
Product ID: 0228-4241_5082cfd3-e748-4c4b-81ba-0957f02244a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA203320
Marketing category: ANDA
Marketing start: 2015-06-17
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .1 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203320-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2015-05-15
A203320-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL			2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203320-001	AB1

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203320-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203320-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE / ORAL		2015-05-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203320-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203320-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203320-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203320-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203320-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203320-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203320-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203320-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203320-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203320-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203320-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203320-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203320-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203320-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203320-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203320-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203320-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203320-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203320-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203320-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203320-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203320-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203320-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203320-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203320-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203320-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203320-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203320-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203320-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203320-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203320-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203320-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203320-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203320-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203320-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203320-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203320-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203320-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203320-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203320-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clonidine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W76I6XXF06	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1013930	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
0100c70d-7fde-46a1-8374-940550a27e43	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	Strength	SPL version
0228-4241-06	Clonidine Hydrochloride	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-4241-06	EA - Each	0228-4241	5417d949-8141-426e-926e-0fc6bde8d0e2	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-4241	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	26	Current NDC, Legacy NDC, 1 package rows	20240315_0100c70d-7fde-46a1-8374-940550a27e43.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 Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	0100c70d-7fde-46a1-8374-940550a27e43	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203320 application number: ANDA203320 ndc (product): 0228-4241

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W76I6XXF06	CLONIDINE HYDROCHLORIDE	4205-91-8	CLONIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1013930	cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet	PSN	0100c70d-7fde-46a1-8374-940550a27e43	27
1013930	12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet	SCD	0100c70d-7fde-46a1-8374-940550a27e43	27
1013930	clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet	SY	0100c70d-7fde-46a1-8374-940550a27e43	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-4241-06	00228424106	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-4241-06)	2015-06-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride	Actavis Pharma, Inc.	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	27
Clonidine Hydrochloride	Bryant Ranch Prepack	2020-10-12	HUMAN PRESCRIPTION DRUG LABEL	3