CLONIDINE HYDROCHLORIDE

Product NDC: 51138-019
11-digit product format: 511380019
Labeler code: 51138
Product ID: 51138-019_da91ee9c-13cb-4ca0-b30c-a2686b7b699f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Med-Health Pharma, LLC
Application: ANDA070923
Marketing category: ANDA
Marketing start: 2011-01-10
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51138-019-30	2019-11-27	C162847	48780-1	9855d018-d655-cd31-e053-dbdaa90ab51a	CLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51138-019-30	CLONIDINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51138-019-30	EA - Each	51138-019	fffe7872-a3c2-4d9f-a384-203f37fd8099	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	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
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
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 [MED-HEALTH PHARMA, LLC]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51138-019	CLONIDINE HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]	2	Legacy NDC, 1 package rows	20130208_23f20b4e-e90a-4634-ab69-168151b4e90b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W76I6XXF06	CLONIDINE HYDROCHLORIDE	4205-91-8	CLONIDINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51138-019-30	51138001930	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
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