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

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

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	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

CLONIDINE HYDROCHLORIDE

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#