Clonidine Hydrochloride

Product NDC: 55154-2577
11-digit product format: 551542577
Labeler code: 55154
Product ID: 55154-2577_bd619b95-aedb-472f-9b42-071041fde304
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA070975
Marketing category: ANDA
Marketing start: 2020-07-30
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .2 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A070975-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070975-001	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 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	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`cb3db0bc1861…`

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	A070975-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE HYDROCHLORIDE	.2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	Internal RxNorm lookup
884185	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
df62817d-2f50-4c27-aaa8-a22f0290c94f	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
55154-2577-0	Clonidine Hydrochloride	10 in 1 BAG	TABLET	10		6
55154-2577-0	Clonidine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2577	CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240726_df62817d-2f50-4c27-aaa8-a22f0290c94f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975 ndc (product): 55154-2577
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	18c873b1-f2fe-4ba9-b384-38e917af373b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	4b889e12-0382-4679-9cec-d6829c59e853	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2e4802eb-c08b-45a2-a222-b0af5db88c7a	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975

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
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	df62817d-2f50-4c27-aaa8-a22f0290c94f	6
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	df62817d-2f50-4c27-aaa8-a22f0290c94f	6
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	df62817d-2f50-4c27-aaa8-a22f0290c94f	6
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	df62817d-2f50-4c27-aaa8-a22f0290c94f	6
884173	clonidine HCl 100 MCG Oral Tablet	SY	df62817d-2f50-4c27-aaa8-a22f0290c94f	6
884185	clonidine HCl 200 MCG Oral Tablet	SY	df62817d-2f50-4c27-aaa8-a22f0290c94f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-2577-0	55154257700	10 BLISTER PACK in 1 BAG (55154-2577-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2020-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	Cardinal Health 107, LLC	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	6