CLONIDINE HYDROCHLORIDE

Product NDC: 53489-217
11-digit product format: 534890217
Labeler code: 53489
Product ID: 53489-217_c0fc5006-ac11-423d-b189-7e95f5fe8d99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mutual Pharmaceutical Company, Inc.
Application: ANDA070923
Marketing category: ANDA
Marketing start: 1987-09-04
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	53489-217		I	Inactivated by FDA		2026-08-03
excluded package	package	53489-217	53489-217-01	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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`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	53489-217-01	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070923-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB		1987-09-04
A070923-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB		1987-09-04
A070923-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		1987-09-04
A070923-004	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.05MG	TABLET / ORAL		RS	2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070923-001	AB
A070923-002	AB
A070923-003	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 · 124 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	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1987-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	1987-09-04	`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	A070923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070923-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070923-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070923-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070923-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070923-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070923-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070923-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070923-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070923-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070923-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070923-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070923-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070923-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070923-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070923-001	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
53489-217-01	2019-11-27	C162847	48780-1	9855e2a2-4218-60a7-e053-dbdaa90a05bd	CLONIDINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53489-217-01	CLONIDINE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-217-01	EA - Each	53489-217	53415f76-a5d7-4b76-8611-1262cf7c2fbd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	5
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-217	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7	Legacy NDC, 1 package rows	20140927_a756191e-085a-4a1a-bb88-b7c174cdcefd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	f65d90dc-11b4-4d63-b4a9-30603bc332ea	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544ea5bf-6713-f034-e063-6394a90a781b	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	TruPharma, LLC	c83e4e4f-bd0e-449d-958a-dc0d570a01ba	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	f30324be-47b6-7f54-e053-2995a90a3ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	00d1562d-b4eb-4d89-95de-0aacee7a82a5	2020-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070923 application number: ANDA070923

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
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e	8
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e	8
884189	clonidine HCl 300 MCG Oral Tablet	SY	8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e	8
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884173	clonidine HCl 100 MCG Oral Tablet	SY	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884185	clonidine HCl 200 MCG Oral Tablet	SY	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884189	clonidine HCl 300 MCG Oral Tablet	SY	a756191e-085a-4a1a-bb88-b7c174cdcefd	7
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	3b373f21-1fdb-4701-9193-1120337f3f98	5
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	3b373f21-1fdb-4701-9193-1120337f3f98	5
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	3b373f21-1fdb-4701-9193-1120337f3f98	5
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	3b373f21-1fdb-4701-9193-1120337f3f98	5
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	3b373f21-1fdb-4701-9193-1120337f3f98	5
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	3b373f21-1fdb-4701-9193-1120337f3f98	5
884173	clonidine HCl 100 MCG Oral Tablet	SY	3b373f21-1fdb-4701-9193-1120337f3f98	5
884185	clonidine HCl 200 MCG Oral Tablet	SY	3b373f21-1fdb-4701-9193-1120337f3f98	5
884189	clonidine HCl 300 MCG Oral Tablet	SY	3b373f21-1fdb-4701-9193-1120337f3f98	5
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884185	clonidine HCl 200 MCG Oral Tablet	SY	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884189	clonidine HCl 300 MCG Oral Tablet	SY	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884185	clonidine HCl 200 MCG Oral Tablet	SY	c1143cd8-4325-4dcf-a12f-8badfdba682f	1
884189	clonidine HCl 300 MCG Oral Tablet	SY	c1143cd8-4325-4dcf-a12f-8badfdba682f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53489-217-01	53489021701	100 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE TABLETS USP	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	8
CLONIDINE HYDROCHLORIDE TABLETS USP	A-S Medication Solutions	2018-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
CLONIDINE HYDROCHLORIDE TABLETS USP	Mutual Pharmaceutical Company, Inc.	2014-09-25	HUMAN PRESCRIPTION DRUG LABEL	7
CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg	Physicians Total Care, Inc.	2012-06-28	HUMAN PRESCRIPTION DRUG LABEL	5
CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg	Med-Health Pharma, LLC	2012-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg	Rebel Distributors Corp	2011-07-20	HUMAN PRESCRIPTION DRUG LABEL	1