clonidine hydrochloride

Product NDC: 43063-925
Requested package NDC: 43063-925-30
11-digit product format: 430630925
Labeler code: 43063
Product ID: 43063-925_52ba35ef-e69a-ca6e-e063-6394a90af9dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078895
Marketing category: ANDA
Marketing start: 2009-09-21
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 · 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.

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
2026-08-01 22:54:32	2026-06	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078895-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078895-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078895-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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.	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 ndc (package): 43063-925-30 ndc (product): 43063-925 ndc11 (package): 43063092530
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	REMEDYREPACK INC.	e5d24f52-e0c2-428d-b647-481d63ffd95f	2026-04-06	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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ea1527a5-4939-4ff7-a827-f88a9113a07d	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
43063-925-30	clonidine hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-925-30	EA - Each	43063-925	715d1c8e-ee52-48b2-b335-b70399a46403	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-925	CLONIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 1 package rows	20241018_ea1527a5-4939-4ff7-a827-f88a9113a07d.zip

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	ea1527a5-4939-4ff7-a827-f88a9113a07d	15
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	ea1527a5-4939-4ff7-a827-f88a9113a07d	15
884185	clonidine HCl 200 MCG Oral Tablet	SY	ea1527a5-4939-4ff7-a827-f88a9113a07d	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-925-30	43063092530	30 TABLET in 1 BOTTLE, PLASTIC (43063-925-30)	30 tablet	2019-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	15