CLONIDINE HYDROCHLORIDE

Product NDC: 53489-215
11-digit product format: 534890215
Labeler code: 53489
Product ID: 53489-215_c0fc5006-ac11-423d-b189-7e95f5fe8d99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mutual Pharmaceutical Company, Inc.
Application: ANDA070925
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53489-215		I	Inactivated by FDA	2026-10-05
excluded package	package	53489-215	53489-215-01	I	Inactivated by FDA	2026-10-05
excluded package	package	53489-215	53489-215-10	I	Inactivated by FDA	2026-10-05

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 2 · 66 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	53489-215-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-215-01	`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	53489-215-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-215-01	`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	53489-215-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-215-01	`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	53489-215-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-215-01	`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	53489-215-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-215-01	`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	53489-215-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-215-01	`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	53489-215-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-215-01	`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	53489-215-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-215-01	`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	53489-215-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53489-215-01	`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	53489-215-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53489-215-01	`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	53489-215-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53489-215-01	`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	53489-215-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53489-215-01	`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	53489-215-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53489-215-01	`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	53489-215-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53489-215-01	`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	53489-215-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53489-215-01	`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	53489-215-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53489-215-01	`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	53489-215-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53489-215-01	`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	53489-215-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53489-215-01	`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	53489-215-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53489-215-01	`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	53489-215-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53489-215-01	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
53489-215-01	2019-11-27	C162847	48780-1	9855e2a2-4218-60a7-e053-dbdaa90a05bd	CLONIDINE HYDROCHLORIDE TABLETS USP
53489-215-10	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
53489-215-01	CLONIDINE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET	100		7
53489-215-10	CLONIDINE HYDROCHLORIDE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-215-01	EA - Each	53489-215	df28f9d9-58d9-4c3f-b5c2-6f9b98f896a7	1	2012-07-24
53489-215-10	EA - Each	53489-215	4260d501-125f-4f52-b01d-1f5f67d16705	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 [AIDAREX PHARMACEUTICALS LLC]	4
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	4
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	2
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	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 [MED-HEALTH PHARMA, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-215	CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7	Legacy NDC, 2 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 · 7 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	cee049ea-a476-433c-971f-2466a6a3263b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	50c8a725-a449-256b-e063-6294a90a3e44	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7484e8fa-13a7-70e9-e053-2a91aa0a24b7	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	df603f27-d341-3957-e053-2995a90a825f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	d072d601-b3d2-46e0-af1f-98adc9572f4a	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	33c68d5e-6a68-40fd-a326-bf36a7e01d5b	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070925 application number: ANDA070925

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	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	d072d601-b3d2-46e0-af1f-98adc9572f4a	4
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	bd72d919-3ac4-4779-aa98-a028363534e9	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	bd72d919-3ac4-4779-aa98-a028363534e9	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	d072d601-b3d2-46e0-af1f-98adc9572f4a	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	bd72d919-3ac4-4779-aa98-a028363534e9	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	d072d601-b3d2-46e0-af1f-98adc9572f4a	4
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	29283327-3a8a-486d-a9fc-ba5cdc91a09b	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	f4451e3e-5540-42a7-891d-fe0b7dfc655f	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	f4451e3e-5540-42a7-891d-fe0b7dfc655f	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	23f20b4e-e90a-4634-ab69-168151b4e90b	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	29283327-3a8a-486d-a9fc-ba5cdc91a09b	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	29283327-3a8a-486d-a9fc-ba5cdc91a09b	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	f4451e3e-5540-42a7-891d-fe0b7dfc655f	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	2b12df1f-5915-4431-a70b-bc440cf11aa4	1
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	2b12df1f-5915-4431-a70b-bc440cf11aa4	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
884173	clonidine HCl 100 MCG Oral Tablet	SY	2b12df1f-5915-4431-a70b-bc440cf11aa4	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
53489-215-01	53489021501	100 in 1 BOTTLE, PLASTIC	Historical
53489-215-10	53489021510	1000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE TABLETS USP	Proficient Rx LP	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
CLONIDINE HYDROCHLORIDE TABLETS USP	NuCare Pharmaceuticals,Inc.	2017-08-04	HUMAN PRESCRIPTION DRUG LABEL	1
CLONIDINE HYDROCHLORIDE TABLETS USP	NuCare Pharmaceuticals, Inc.	2016-12-14	HUMAN PRESCRIPTION DRUG LABEL	1
CLONIDINE HYDROCHLORIDE TABLETS USP	Mutual Pharmaceutical Company, Inc.	2014-09-25	HUMAN PRESCRIPTION DRUG LABEL	7
CLONIDINE HYDROCHLORIDE TABLETS USP	Aidarex Pharmaceuticals LLC	2013-12-18	HUMAN PRESCRIPTION DRUG LABEL	4
CLONIDINE HYDROCHLORIDE TABLETS USP	TYA Pharmaceuticals	2013-02-05	HUMAN PRESCRIPTION DRUG LABEL	2
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
CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1 mg	Contract Pharmacy Services-PA	2010-08-18	HUMAN PRESCRIPTION DRUG LABEL	2
CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg	State of Florida DOH Central Pharmacy	2010-05-21	HUMAN PRESCRIPTION DRUG LABEL	1