Clonidine Hydrochloride

Product NDC: 63629-1208
11-digit product format: 636291208
Labeler code: 63629
Product ID: 63629-1208_bd8186d6-46d1-41e6-9b8c-f8600d843aa8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209757
Marketing category: ANDA
Marketing start: 2018-02-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-1208		D	Discontinued by firm		2026-08-17
excluded package	package	63629-1208	63629-1208-1	D	Discontinued by firm		2026-08-17

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

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
A209757-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209757-001	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 · 42 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	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209757-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2017-11-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A209757-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209757-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209757-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209757-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209757-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209757-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209757-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209757-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209757-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209757-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209757-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209757-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209757-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209757-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209757-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209757-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209757-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209757-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209757-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209757-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209757-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209757-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209757-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209757-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209757-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209757-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209757-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209757-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209757-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209757-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209757-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209757-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209757-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209757-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209757-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209757-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209757-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209757-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209757-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209757-001	AB1	1	`e64feba35796…`

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
63629-1208-1	Clonidine Hydrochloride	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1208-1	EA - Each	63629-1208	43175606-dcc9-4e18-b2f9-d94b1fbd4982	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1208	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20240719_9fb36ee3-3d93-4c2e-b399-691305bac715.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	36bd0f0e-5569-466a-ab1b-90eb39efdd68	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209757 application number: ANDA209757
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Solco Healthcare LLC	03a53175-d301-4001-b28b-78ecd763c4ae	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209757 application number: ANDA209757
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Xiamen LP Pharmaceutical Co., Ltd.	7676af27-4d8f-49c4-a50f-6b0892e73c8f	2020-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209757 application number: ANDA209757

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	9fb36ee3-3d93-4c2e-b399-691305bac715	103
1013930	12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet	SCD	9fb36ee3-3d93-4c2e-b399-691305bac715	103
1013930	clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet	SY	9fb36ee3-3d93-4c2e-b399-691305bac715	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1208-1	63629120801	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1208-1)	2024-07-08	0000-00-00	No	No	Current