clonidine hydrochloride

Product NDC: 66116-521
11-digit product format: 661160521
Labeler code: 66116
Product ID: 66116-521_47072dcb-fe13-4aa3-849b-b7b3fbb94c51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: MedVantx, Inc.
Application: ANDA091368
Marketing category: ANDA
Marketing start: 2011-12-13
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66116-521		I	Inactivated by FDA		2026-08-03
excluded package	package	66116-521	66116-521-30	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66116-521-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66116-521-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66116-521-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66116-521-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66116-521-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66116-521-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66116-521-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66116-521-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66116-521-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66116-521-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66116-521-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66116-521-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66116-521-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66116-521-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66116-521-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66116-521-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66116-521-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66116-521-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66116-521-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66116-521-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66116-521-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66116-521-30	`110d247fa046…`	`a55b01930146…`

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	Approval date
A091368-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06
A091368-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06
A091368-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091368-001	AB
A091368-002	AB
A091368-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`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	A091368-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091368-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091368-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091368-001	AB	1	`8072bd15b7f6…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66116-521-30	2019-11-27	C162847	48780-1	9855d018-dbfb-cd31-e053-dbdaa90ab51a	Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66116-521-30	clonidine hydrochloride	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66116-521	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1	Legacy NDC, 1 package rows	20130821_47072dcb-fe13-4aa3-849b-b7b3fbb94c51.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	574640a5-829d-4e9d-be32-832a48cbd8dd	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	2a183d05-5be7-43e9-a084-700ec05d01e9	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	666e757e-9b43-2e40-e053-2991aa0a59a2	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	56a80e79-9cfe-4361-a90a-9245632efa05	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	770b56aa-fcf3-4327-98d1-d87e5a037234	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	VERITYRX, LLC	42788adf-a54d-3545-e063-6394a90a8c69	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	746dcdfd-7dfb-4a29-e053-2991aa0a8a4c	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	100a31f2-9a8e-4245-a09c-05583c3244c3	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	1c13555e-acfc-4a3a-93cd-e6f012f36c61	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5366a055-47fd-41eb-81d8-ffb3be1dc38c	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	61b56917-1442-4068-86d8-0e5a5a59e612	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	329382fb-ccf8-488d-a0b2-68ff959a0846	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	be6c29cd-1692-4dd3-868e-7efcb3a85056	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a9de8b29-5cd2-a49d-e053-2995a90a4f0e	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	DirectRX	2823a922-3217-6062-e054-00144ff88e88	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	88a8db46-0fc9-48cd-b7cc-ac9c9cdea100	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	b60034a6-b8ba-4e54-9ef0-029965e67bc0	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368

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	47072dcb-fe13-4aa3-849b-b7b3fbb94c51	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	47072dcb-fe13-4aa3-849b-b7b3fbb94c51	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	47072dcb-fe13-4aa3-849b-b7b3fbb94c51	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66116-521-30	66116052130	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clonidine hydrochloride	MedVantx, Inc. \| Alembic Pharmaceuticals Limited \| Blenheim Pharmacal, Inc.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	1