clonidine hydrochloride

Product NDC: 29300-468
11-digit product format: 293000468
Labeler code: 29300
Product ID: 29300-468_d015993c-74da-4faa-9e51-727d6d93a867
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA078895
Marketing category: ANDA
Marketing start: 2020-12-24
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .1 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.

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	RLD / RS	Approval date	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		2009-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	RS	2009-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078895-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		2009-08-26	`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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078895-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078895-001	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	.1 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
21bfa28f-20df-43fd-bb80-b720d3b40696	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	SPL version
29300-468-01	clonidine hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	11
29300-468-05	clonidine hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	11
29300-468-10	clonidine hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	11
29300-468-50	clonidine hydrochloride	5000 in 1 BOTTLE, PLASTIC	TABLET	5000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-468-01	EA - Each	29300-468	98f1f067-f8b2-47bd-b6fd-63afb00a45d1	1	2021-04-08
29300-468-05	EA - Each	29300-468	f45ac6b0-545d-4eb8-9ef2-f8181186b666	1	2021-03-02
29300-468-10	EA - Each	29300-468	3669437c-f642-47b4-acc8-992ab28f1364	1	2021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-468	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	9	Current NDC, Legacy NDC, 4 package rows	20201230_21bfa28f-20df-43fd-bb80-b720d3b40696.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.	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	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 ndc (product): 29300-468
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	893a6cf5-d34e-4971-b132-3f5138e481ce	100
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	893a6cf5-d34e-4971-b132-3f5138e481ce	100
884173	clonidine HCl 100 MCG Oral Tablet	SY	893a6cf5-d34e-4971-b132-3f5138e481ce	100
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	c5c85b76-4d5c-47f0-bafb-31efe1fbaed3	31
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	c5c85b76-4d5c-47f0-bafb-31efe1fbaed3	31
884173	clonidine HCl 100 MCG Oral Tablet	SY	c5c85b76-4d5c-47f0-bafb-31efe1fbaed3	31
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	22fbd302-46b5-4bdc-87e2-fda94cb22530	29
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	22fbd302-46b5-4bdc-87e2-fda94cb22530	29
884173	clonidine HCl 100 MCG Oral Tablet	SY	22fbd302-46b5-4bdc-87e2-fda94cb22530	29
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	9d889b1c-9599-44fa-9e47-6261fbf2837e	26
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	9d889b1c-9599-44fa-9e47-6261fbf2837e	26
884173	clonidine HCl 100 MCG Oral Tablet	SY	9d889b1c-9599-44fa-9e47-6261fbf2837e	26
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	e5d24f52-e0c2-428d-b647-481d63ffd95f	15
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	e5d24f52-e0c2-428d-b647-481d63ffd95f	15
884173	clonidine HCl 100 MCG Oral Tablet	SY	e5d24f52-e0c2-428d-b647-481d63ffd95f	15
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	clonidine HCl 100 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	clonidine HCl 200 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	clonidine HCl 300 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	55ab721b-7b4c-42d5-99e3-745008fe139c	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	55ab721b-7b4c-42d5-99e3-745008fe139c	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	55ab721b-7b4c-42d5-99e3-745008fe139c	4
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	1ab3b82f-db7f-22bf-e063-6294a90ae93f	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	1ab3b82f-db7f-22bf-e063-6294a90ae93f	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	1ab3b82f-db7f-22bf-e063-6294a90ae93f	3
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	32d72d7b-5881-f431-e063-6394a90a3547	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	200afa03-adf3-4dca-8de8-1569701bd029	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	38680c1d-3929-40d5-bda9-4eea5693afca	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	300b4437-74b3-119b-e063-6394a90a0d0f	2
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	200afa03-adf3-4dca-8de8-1569701bd029	2
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	200afa03-adf3-4dca-8de8-1569701bd029	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	300b4437-74b3-119b-e063-6394a90a0d0f	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	38680c1d-3929-40d5-bda9-4eea5693afca	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	32d72d7b-5881-f431-e063-6394a90a3547	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	200afa03-adf3-4dca-8de8-1569701bd029	2
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	200afa03-adf3-4dca-8de8-1569701bd029	2
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	200afa03-adf3-4dca-8de8-1569701bd029	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	32d72d7b-5881-f431-e063-6394a90a3547	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	38680c1d-3929-40d5-bda9-4eea5693afca	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	300b4437-74b3-119b-e063-6394a90a0d0f	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	200afa03-adf3-4dca-8de8-1569701bd029	2
884185	clonidine HCl 200 MCG Oral Tablet	SY	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884185	clonidine HCl 200 MCG Oral Tablet	SY	200afa03-adf3-4dca-8de8-1569701bd029	2
884189	clonidine HCl 300 MCG Oral Tablet	SY	200afa03-adf3-4dca-8de8-1569701bd029	2
884189	clonidine HCl 300 MCG Oral Tablet	SY	fcebe343-18ad-d4cd-e053-6294a90a72d5	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	427939a4-6bbf-0d80-e063-6294a90aa2a0	1
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	29657015-e865-56a7-e063-6394a90af6df	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	427939a4-6bbf-0d80-e063-6294a90aa2a0	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	29657015-e865-56a7-e063-6394a90af6df	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	427939a4-6bbf-0d80-e063-6294a90aa2a0	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	29657015-e865-56a7-e063-6394a90af6df	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-468-01	29300046801	100 TABLET in 1 BOTTLE, PLASTIC (29300-468-01)	100 tablet	2020-12-24	0000-00-00	No	No	Current
29300-468-05	29300046805	500 TABLET in 1 BOTTLE, PLASTIC (29300-468-05)	500 tablet	2020-12-24	0000-00-00	No	No	Current
29300-468-10	29300046810	1000 TABLET in 1 BOTTLE, PLASTIC (29300-468-10)	1000 tablet	2020-12-24	0000-00-00	No	No	Current
29300-468-50	29300046850	5000 TABLET in 1 BOTTLE, PLASTIC (29300-468-50)	5000 tablet	2020-12-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	REMEDYREPACK INC.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	16
Clonidine Hydrochloride Tablets, USP	St. Mary's Medical Park Pharmacy	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	3
Clonidine Hydrochloride Tablets, USP	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	2
Clonidine Hydrochloride Tablets, USP	Preferred Pharmaceuticals Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	4
Clonidine Hydrochloride Tablets, USP	Unichem Pharmaceuticals (USA), Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	11
Clonidine Hydrochloride Tablets, USP	NuCare Pharmaceuticals,Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
Clonidine Hydrochloride Tablets, USP	VERITYRX, LLC	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine Hydrochloride Tablets, USP	Redpharm Drug	2025-08-30	HUMAN PRESCRIPTION DRUG LABEL	2
Clonidine Hydrochloride Tablets, USP Rx Only	AvPAK	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
Clonidine Hydrochloride Tablets, USP	Coupler LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine Hydrochloride Tablets, USP	A-S Medication Solutions	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	31
Clonidine Hydrochloride Tablets, USP	A-S Medication Solutions	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	26
Clonidine Hydrochloride Tablets, USP	A-S Medication Solutions	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	29
Clonidine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2023-11-30	HUMAN PRESCRIPTION DRUG LABEL	100
Clonidine Hydrochloride Tablets, USP	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2