clonidine hydrochloride

Product NDC: 29300-135
11-digit product format: 293000135
Labeler code: 29300
Product ID: 29300-135_5929c96f-9fa9-4399-84aa-28584da9966a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA078895
Marketing category: ANDA
Marketing start: 2009-09-21
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: No
Listing certified through: 2021-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-135-01	clonidine hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	11
29300-135-05	clonidine hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	11
29300-135-10	clonidine hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	11
29300-135-50	clonidine hydrochloride	5000 in 1 BOTTLE, PLASTIC	TABLET	5000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-135-01	EA - Each	29300-135	802fcbc3-7ac4-49ba-8894-92a521409c44	1	2013-02-13
29300-135-05	EA - Each	29300-135	93076f91-fb24-4a46-9efb-0a2d677b8d94	1	2015-01-05
29300-135-10	EA - Each	29300-135	c5738668-9b0b-47a0-b501-b8660f70979a	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 [UNICHEM PHARMACEUTICALS (USA), INC.]	4
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-135	CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	9	Legacy NDC, 4 package rows	20201230_21bfa28f-20df-43fd-bb80-b720d3b40696.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
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	7852d51c-340d-4756-8127-37e5a1763bb0	100
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	7852d51c-340d-4756-8127-37e5a1763bb0	100
884173	clonidine HCl 100 MCG Oral Tablet	SY	7852d51c-340d-4756-8127-37e5a1763bb0	100
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884173	clonidine HCl 100 MCG Oral Tablet	SY	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884185	clonidine HCl 200 MCG Oral Tablet	SY	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884189	clonidine HCl 300 MCG Oral Tablet	SY	70c0c9f4-075d-4621-ae13-e8f03d814d5f	30
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	clonidine HCl 100 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884185	clonidine HCl 200 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884189	clonidine HCl 300 MCG Oral Tablet	SY	21bfa28f-20df-43fd-bb80-b720d3b40696	11
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884173	clonidine HCl 100 MCG Oral Tablet	SY	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884185	clonidine HCl 200 MCG Oral Tablet	SY	e938a4ed-9f7f-48bb-b7a4-b0784496e860	7
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	4c55668e-8a40-4f07-b60f-5b74c977757b	6
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	4c55668e-8a40-4f07-b60f-5b74c977757b	6
884173	clonidine HCl 100 MCG Oral Tablet	SY	4c55668e-8a40-4f07-b60f-5b74c977757b	6
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	3d966e77-9331-4051-e054-00144ff8d46c	5
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	3d966e77-9331-4051-e054-00144ff8d46c	5
884173	clonidine HCl 100 MCG Oral Tablet	SY	3d966e77-9331-4051-e054-00144ff8d46c	5
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	4ecb7bdc-4a46-7444-e054-00144ff88e88	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	4ecb7bdc-4a46-7444-e054-00144ff88e88	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	4ecb7bdc-4a46-7444-e054-00144ff88e88	3
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	b7254589-9277-6fcf-e053-2a95a90a05fd	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	b7254589-9277-6fcf-e053-2a95a90a05fd	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	b7254589-9277-6fcf-e053-2a95a90a05fd	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	7d64e589-c07c-143c-e053-2991aa0a6ca3	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	7d64e589-c07c-143c-e053-2991aa0a6ca3	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	7d64e589-c07c-143c-e053-2991aa0a6ca3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-135-01	29300013501	100 TABLET in 1 BOTTLE, PLASTIC (29300-135-01)	100 tablet	2009-09-21	0000-00-00	No	No	Current
29300-135-05	29300013505	500 TABLET in 1 BOTTLE, PLASTIC (29300-135-05)	500 tablet	2009-09-21	0000-00-00	No	No	Current
29300-135-10	29300013510	1000 TABLET in 1 BOTTLE, PLASTIC (29300-135-10)	1000 tablet	2009-09-21	0000-00-00	No	No	Current
29300-135-50	29300013550	5000 TABLET in 1 BOTTLE, PLASTIC (29300-135-50)	5000 tablet	2009-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	Unichem Pharmaceuticals (USA), Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	11
Clonidine Hydrochloride Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	18
Clonidine Hydrochloride Tablets, USP	A-S Medication Solutions	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	30
Clonidine Hydrochloride Tablets USP	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	5
CLONIDINE HYDROCHLORIDE	DirectRX	2023-05-12	HUMAN PRESCRIPTION DRUG LABEL	6
Clonidine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
clonidine hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Clonidine Hydrochloride Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Clonidine Hydrochloride Tablets USP	Clinical Solutions Wholesale, LLC	2020-09-24	HUMAN PRESCRIPTION DRUG LABEL	7
Clonidine Hydrochloride Tablets, USP	medsource pharmaceuticals	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	1

clonidine hydrochloride

DailyMed Product Concepts#

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#