Clonidine Hydrochloride

Product NDC: 50090-3151
Requested package NDC: 50090-3151-6
11-digit product format: 500903151
Labeler code: 50090
Product ID: 50090-3151_f4afd701-7765-4cc8-a50a-8eaddf4a5d8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA070975
Marketing category: ANDA
Marketing start: 1995-01-03
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3151	50090-3151-6	D	Discontinued by firm		2026-08-03

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
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`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
A070975-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	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
A070975-001	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	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	CLONIDINE HYDROCHLORIDE	0.2MG	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	A070975-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070975-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070975-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070975-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070975-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070975-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070975-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070975-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070975-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070975-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070975-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070975-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070975-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070975-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070975-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070975-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070975-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070975-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070975-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070975-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070975-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070975-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070975-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070975-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070975-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070975-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070975-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070975-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070975-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070975-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070975-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070975-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070975-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070975-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070975-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070975-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070975-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070975-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070975-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070975-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3151-0	2024-10-23	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-1	2024-10-23	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-5	2024-10-23	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-6	2024-10-23	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-0	2023-01-30	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-1	2023-01-30	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-5	2023-01-30	Clonidine Hydrochloride Tablets, USP Rx only
50090-3151-6	2023-01-30	Clonidine Hydrochloride Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3151-0	EA - Each	50090-3151	839e5e10-e69d-4eaf-b3b6-48752daad59f	1	2021-09-07
50090-3151-1	EA - Each	50090-3151	d6404a46-70a7-4a5d-a496-e2185edcca53	1	2021-09-07
50090-3151-5	EA - Each	50090-3151	0d965bd6-d1b3-49b7-b306-b7ec0f22d355	1	2019-05-02
50090-3151-6	EA - Each	50090-3151	98e60942-78fe-4a25-93f2-75463e21c1bd	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3151	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	10	Legacy NDC	20241025_45cdea70-65fd-4931-8f95-77f12823f7b6.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	547beb0f-0c12-2ef4-e063-6394a90a6a73	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	266af0b1-ce85-6699-e063-6394a90acb4d	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	18c873b1-f2fe-4ba9-b384-38e917af373b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	4b889e12-0382-4679-9cec-d6829c59e853	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2e4802eb-c08b-45a2-a222-b0af5db88c7a	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070975 application number: ANDA070975

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W76I6XXF06	CLONIDINE HYDROCHLORIDE	4205-91-8	CLONIDINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3151-6	50090315106	90 TABLET in 1 BOTTLE, PLASTIC (50090-3151-6)	90 tablet	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP Rx only	A-S Medication Solutions	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	10