clonidine hydrochloride

Product NDC: 45865-797
11-digit product format: 458650797
Labeler code: 45865
Product ID: 45865-797_7d64e589-c07d-143c-e053-2991aa0a6ca3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA078895
Marketing category: ANDA
Marketing start: 2009-09-21
Marketing end: 0000-00-00
Substance: CLONIDINE HYDROCHLORIDE
Active strength: 0 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

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	45865-797		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-797	45865-797-30	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-797-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-797-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-797-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-797-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-797-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-797-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-797-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-797-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-797-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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	RLD / RS	Approval date
A078895-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26
A078895-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26
A078895-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078895-001	AB
A078895-002	AB
A078895-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078895-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078895-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078895-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078895-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078895-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078895-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078895-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078895-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078895-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078895-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078895-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078895-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078895-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078895-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078895-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078895-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078895-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-001	AB	1	`1e350fbaab3a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-797-30	2025-01-30	C162847	48780-1	2cef2736-70fa-d83d-e063-dadaa90ab31f	Clonidine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-797-30	clonidine hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-797	CLONIDINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181220_7d64e589-c07c-143c-e053-2991aa0a6ca3.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e5d24f52-e0c2-428d-b647-481d63ffd95f	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e96ab74c-eedf-4d71-8a35-d5ec3daa7592	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	32d72d7b-5881-f431-e063-6394a90a3547	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ea1527a5-4939-4ff7-a827-f88a9113a07d	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be1b921d-152e-4bd5-82bd-56e2f8beef3e	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	ASCLEMED USA INC.	200afa03-adf3-4dca-8de8-1569701bd029	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	55ab721b-7b4c-42d5-99e3-745008fe139c	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	21bfa28f-20df-43fd-bb80-b720d3b40696	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1ab3b82f-db7f-22bf-e063-6294a90ae93f	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	ab2ffb6e-7070-063b-e053-2a95a90aff22	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	VERITYRX, LLC	427939a4-6bbf-0d80-e063-6294a90aa2a0	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	300b4437-74b3-119b-e063-6394a90a0d0f	2025-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	AvPAK	fcebe343-18ad-d4cd-e053-6294a90a72d5	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	c5c85b76-4d5c-47f0-bafb-31efe1fbaed3	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	9d889b1c-9599-44fa-9e47-6261fbf2837e	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	70c0c9f4-075d-4621-ae13-e8f03d814d5f	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	415b168c-1267-2777-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	22fbd302-46b5-4bdc-87e2-fda94cb22530	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	893a6cf5-d34e-4971-b132-3f5138e481ce	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	38680c1d-3929-40d5-bda9-4eea5693afca	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078895 application number: ANDA078895

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	7d64e589-c07c-143c-e053-2991aa0a6ca3	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	7d64e589-c07c-143c-e053-2991aa0a6ca3	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	7d64e589-c07c-143c-e053-2991aa0a6ca3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-797-30	45865079730	30 TABLET in 1 BOTTLE, PLASTIC (45865-797-30)	30 tablet	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	medsource pharmaceuticals	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	1