Clonidine Hydrochloride

Product NDC: 59651-233
11-digit product format: 596510233
Labeler code: 59651
Product ID: 59651-233_2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA070886
Marketing category: ANDA
Marketing start: 2021-06-02
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070886-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31
A070886-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31
A070886-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A070886-001	AB
A070886-002	AB
A070886-003	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 4 · 123 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	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-002	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1988-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070886-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1988-08-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 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	A070886-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070886-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070886-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070886-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070886-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070886-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070886-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070886-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070886-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070886-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070886-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070886-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070886-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070886-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070886-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070886-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070886-001	AB	1	`8072bd15b7f6…`

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	.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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	Internal RxNorm lookup
884185	Internal RxNorm lookup
884189	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
2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	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
59651-233-01	Clonidine Hydrochloride	100 in 1 BOTTLE	TABLET	100		1
59651-233-05	Clonidine Hydrochloride	500 in 1 BOTTLE	TABLET	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-233-01	EA - Each	59651-233	36aaa52c-8e19-4e87-8fcf-74632ab262be	1	2023-04-07
59651-233-05	EA - Each	59651-233	5845b446-d16f-4d4c-bfde-be71c27b22f2	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-233	CLONIDINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	1	Current NDC, Legacy NDC, 2 package rows	20220609_2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb.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 · 5 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	b359baee-6faf-4f7d-be86-ba7a1b1de770	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0906c25f-e5b8-4a08-9b10-d1f06419e275	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	c8e151d6-50c6-47a1-80b0-bd8e07acddd2	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	c7f473df-94ab-41db-8cc7-9a159d5e6dc4	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	2022-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070886 application number: ANDA070886 ndc (product): 59651-233

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
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	b359baee-6faf-4f7d-be86-ba7a1b1de770	100
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	b359baee-6faf-4f7d-be86-ba7a1b1de770	100
884185	clonidine HCl 200 MCG Oral Tablet	SY	b359baee-6faf-4f7d-be86-ba7a1b1de770	100
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884185	clonidine HCl 200 MCG Oral Tablet	SY	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1
884189	clonidine HCl 300 MCG Oral Tablet	SY	2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-233-01	59651023301	100 TABLET in 1 BOTTLE (59651-233-01)	100 tablet	2021-06-02	0000-00-00	No	No	Current
59651-233-05	59651023305	500 TABLET in 1 BOTTLE (59651-233-05)	500 tablet	2021-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	100
Clonidine Hydrochloride Tablets, USP	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2022-06-08	Human Prescription Drug Label	1