Clonidine Hydrochloride

Product NDC: 68071-4661
Requested package NDC: 68071-4661-9
11-digit product format: 680714661
Labeler code: 68071
Product ID: 68071-4661_2bed1bae-519d-1bb9-e063-6294a90a795b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA070974
Marketing category: ANDA
Marketing start: 1995-01-03
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: 2026-12-31
Current FDA listing: Yes

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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070974-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070974-001	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 2 · 41 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	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A070974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070974-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070974-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070974-001	AB	1	`cb3db0bc1861…`

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	.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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	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
7cd64137-09d7-7a00-e053-2a91aa0a06ae	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-12	CLONIDINE HYDROCHLORIDE TABLETS, USP
2023-01-30	CLONIDINE HYDROCHLORIDE TABLETS, USP
2021-02-17	CLONIDINE HYDROCHLORIDE TABLETS, USP
2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4661-2	Clonidine Hydrochloride	120 in 1 BOTTLE	TABLET	120		6
68071-4661-9	Clonidine Hydrochloride	90 in 1 BOTTLE	TABLET	90		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4661	CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250119_7cd64137-09d7-7a00-e053-2a91aa0a06ae.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	7ec53e25-c50a-48b4-82b0-c0b3626f31dc	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	66dc3cf0-d6bd-436c-9a7f-7477575b3260	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	00c6d67a-bb11-4884-9eeb-4e1b8701a08b	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4b087e-a81a-1321-e053-2995a90a2b9f	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cd64137-09d7-7a00-e053-2a91aa0a06ae	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974 ndc (package): 68071-4661-9 ndc (product): 68071-4661 ndc11 (package): 68071466109
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0bde4636-7f34-467e-b9b9-8d281145177d	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974

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	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6
884173	clonidine HCl 100 MCG Oral Tablet	SY	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4661-9	68071466109	90 TABLET in 1 BOTTLE (68071-4661-9)	90 tablet	2018-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	6