Clonidine hydrochloride

Product NDC: 51655-445
11-digit product format: 516550445
Labeler code: 51655
Product ID: 51655-445_490edb25-d3c2-8b45-e063-6394a90a9bc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA070925
Marketing category: ANDA
Marketing start: 2020-10-01
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .1 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: Clonidine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE HYDROCHLORIDE	.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W76I6XXF06	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
df603f27-d341-3957-e053-2995a90a825f	Available on FDA.report

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
51655-445-18	Clonidine hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	3
51655-445-25	Clonidine hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	3
51655-445-26	Clonidine hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	3
51655-445-52	Clonidine hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-445	CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2	Current NDC, 4 package rows	20240627_df603f27-d341-3957-e053-2995a90a825f.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 ndc (product): 51655-445
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	df603f27-d341-3957-e053-2995a90a825f	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	df603f27-d341-3957-e053-2995a90a825f	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	df603f27-d341-3957-e053-2995a90a825f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-445-18	51655044518	180 TABLET in 1 BOTTLE, PLASTIC (51655-445-18)	180 tablet	2022-03-23	No	No	Current
51655-445-25	51655044525	60 TABLET in 1 BOTTLE, PLASTIC (51655-445-25)	60 tablet	2022-08-26	No	No	Current
51655-445-26	51655044526	90 TABLET in 1 BOTTLE, PLASTIC (51655-445-26)	90 tablet	2024-03-05	No	No	Current
51655-445-52	51655044552	30 TABLET in 1 BOTTLE, PLASTIC (51655-445-52)	30 tablet	2020-10-01	No	No	Current