CLONIDINE HYDROCHLORIDE

Product NDC: 63629-2753
11-digit product format: 636292753
Labeler code: 63629
Product ID: 63629-2753_1e17b4e7-c094-456c-aa6d-487945084931
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA070924
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: No
Listing certified through: 2021-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-2753		D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-1	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-2	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-3	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-4	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-5	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-6	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-7	D	Discontinued by firm	2026-10-05
excluded package	package	63629-2753	63629-2753-8	D	Discontinued by firm	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 · 117 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	63629-2753-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2753-4	`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	63629-2753-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2753-4	`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	63629-2753-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2753-4	`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	63629-2753-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2753-4	`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	63629-2753-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2753-4	`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	63629-2753-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2753-4	`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	63629-2753-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2753-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2753-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2753-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2753-7	`302b2466d912…`	`e7b80fea0513…`

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-2753-1	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-2	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-3	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-4	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-5	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-6	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-7	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-8	2020-10-16	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-1	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-2	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-3	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-4	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-5	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-6	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-7	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP
63629-2753-8	2020-01-31	CLONIDINE HYDROCHLORIDE TABLETS USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2753-1	EA - Each	63629-2753	2db9e361-5710-4e8d-b7e5-f73a8640fcbc	1	2012-07-24
63629-2753-2	EA - Each	63629-2753	3d5f099a-aa3d-4a7c-a7ab-39b944d1d39d	1	2012-07-24
63629-2753-3	EA - Each	63629-2753	591162d6-a1d8-4f4e-8085-72d0c4122ed5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1002
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1002

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 · 4 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	a32f4b18-1090-4d79-a56b-39c0cf366bbc	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070924 application number: ANDA070924
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	df77e732-9765-ee5c-e053-2a95a90abc92	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070924 application number: ANDA070924
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Proficient Rx LP	8427eee0-955d-4718-b259-73dab56d36d2	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070924 application number: ANDA070924
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	e8c7aa08-1450-de68-e053-2995a90ad0b6	2022-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070924 application number: ANDA070924

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2753-1	63629275301	30 TABLET in 1 BOTTLE (63629-2753-1)	30 tablet	2006-04-07	0000-00-00	No	No	Current
63629-2753-2	63629275302	60 TABLET in 1 BOTTLE (63629-2753-2)	60 tablet	2006-04-07	0000-00-00	No	No	Current
63629-2753-3	63629275303	100 TABLET in 1 BOTTLE (63629-2753-3)	100 tablet	2006-04-07	0000-00-00	No	No	Current
63629-2753-4	63629275304	90 TABLET in 1 BOTTLE (63629-2753-4)	90 tablet	2006-04-07	0000-00-00	No	No	Current
63629-2753-5	63629275305	120 TABLET in 1 BOTTLE (63629-2753-5)	120 tablet	2006-04-07	0000-00-00	No	No	Current
63629-2753-6	63629275306	14 TABLET in 1 BOTTLE (63629-2753-6)	14 tablet	2005-02-21	0000-00-00	No	No	Current
63629-2753-7	63629275307	15 TABLET in 1 BOTTLE (63629-2753-7)	15 tablet	2005-02-21	0000-00-00	No	No	Current
63629-2753-8	63629275308	20 TABLET in 1 BOTTLE (63629-2753-8)	20 tablet	2005-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE TABLETS USP	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1006