Clonidine Hydrochloride

Product NDC: 43986-004
11-digit product format: 439860004
Labeler code: 43986
Product ID: 43986-004_791339f1-c32a-1a73-e053-2a91aa0acd7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bluepharma - Industria Farmaceutica, S.A.
Application: ANDA211433
Marketing category: ANDA
Marketing start: 2019-03-01
Marketing end: 0000-00-00
Substance: CLONIDINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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…`

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride	Bluepharma - Industria Farmaceutica, S.A.	2018-04-01	HUMAN PRESCRIPTION DRUG LABEL	1

Clonidine Hydrochloride

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#