Clonidine hydrochloride

Product NDC: 52817-183
11-digit product format: 528170183
Labeler code: 52817
Product ID: 52817-183_4feb108f-0b2f-75d1-e063-6394a90a6152
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: TruPharma, LLC
Application: ANDA070923
Marketing category: ANDA
Marketing start: 2026-04-13
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .05 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070923-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB		1987-09-04
A070923-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		1987-09-04
A070923-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		1987-09-04
A070923-004	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.05MG	TABLET / ORAL		RS	2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070923-001	AB
A070923-002	AB
A070923-003	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 · 124 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	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A070923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	AB	1	`8072bd15b7f6…`

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	.05 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	Internal RxNorm lookup
884185	Internal RxNorm lookup
884189	Internal RxNorm lookup
2740803	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
c83e4e4f-bd0e-449d-958a-dc0d570a01ba	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
52817-183-10	Clonidine hydrochloride	100 in 1 BOTTLE	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-183-10	EA - Each	52817-183	2c2e9a2d-2bac-47bc-8a44-50907a85bae3	1	2026-05-22

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 · 6 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	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923 ndc (product): 52817-183
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	f30324be-47b6-7f54-e053-2995a90a3ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	00d1562d-b4eb-4d89-95de-0aacee7a82a5	2020-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923

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	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
2740803	cloNIDine hydrochloride 0.05 MG Oral Tablet	PSN	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
2740803	clonidine hydrochloride 0.05 MG Oral Tablet	SCD	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884173	clonidine HCl 100 MCG Oral Tablet	SY	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884185	clonidine HCl 200 MCG Oral Tablet	SY	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
884189	clonidine HCl 300 MCG Oral Tablet	SY	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10
2740803	clonidine hydrochloride 50 MCG Oral Tablet	SY	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52817-183-10	52817018310	100 TABLET in 1 BOTTLE (52817-183-10)	100 tablet	2026-04-13	No	No	Current