Clonidine Hydrochloride

Product NDC: 70518-1811
Requested package NDC: 70518-1811-1
11-digit product format: 705181811
Labeler code: 70518
Product ID: 70518-1811_ea26840f-e0e2-097e-e053-2a95a90a9f16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA070976
Marketing category: ANDA
Marketing start: 2019-01-23
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: 2023-12-31
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	70518-1811	70518-1811-1	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A070976-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	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
A070976-001	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	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070976-001	CLONIDINE HYDROCHLORIDE	0.3MG	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	A070976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070976-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070976-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070976-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070976-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070976-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070976-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070976-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070976-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070976-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070976-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070976-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070976-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070976-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070976-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070976-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070976-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070976-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070976-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	acdddd91-ffe3-4b9b-9c59-0328e018b662	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e9b22c56-a3fc-46df-b745-11c4ac309a91	2017-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070976 application number: ANDA070976

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
70518-1811-1	70518181101	90 TABLET in 1 BOTTLE, PLASTIC (70518-1811-1)	90 tablet	2019-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	7