Clonidine Hydrochloride

Product NDC: 70069-044
11-digit product format: 700690044
Labeler code: 70069
Product ID: 70069-044_b1e7ffe5-7d5f-4e02-a9c9-3d9ad3fac23e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Somerset Therapeutics, LLC
Application: ANDA211433
Marketing category: ANDA
Marketing start: 2025-03-04
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211433-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211433-001	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 2 · 41 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	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211433-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL		2018-10-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211433-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211433-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211433-001	AB1	1	`6a471c1ec25d…`
2021-12-28 21:50 UTC	2021-12	A211433-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211433-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211433-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211433-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211433-001	AB1	1	`c0c555d07b60…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211433-001	AB1	1	`a50c72e98297…`

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
1b4fb182-8194-4fdd-bf9b-f7e60e734179	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
70069-044-01	Clonidine Hydrochloride	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-044-01	EA - Each	70069-044	db3af06d-c309-4222-a868-47fd64792b7a	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-044	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SOMERSET THERAPEUTICS, LLC]	1	Current NDC, 1 package rows	20250311_1b4fb182-8194-4fdd-bf9b-f7e60e734179.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	Somerset Therapeutics, LLC	1b4fb182-8194-4fdd-bf9b-f7e60e734179	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211433 application number: ANDA211433 ndc (product): 70069-044

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	1b4fb182-8194-4fdd-bf9b-f7e60e734179	1
1013930	12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet	SCD	1b4fb182-8194-4fdd-bf9b-f7e60e734179	1
1013930	clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet	SY	1b4fb182-8194-4fdd-bf9b-f7e60e734179	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70069-044-01	70069004401	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70069-044-01)	2025-03-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride	Somerset Therapeutics, LLC \| Bluepharma – Industria Farmaceutica, S.A.	2025-03-07	HUMAN PRESCRIPTION DRUG LABEL	1