Clonidine Hydrochloride

Product NDC: 54738-908
11-digit product format: 547380908
Labeler code: 54738
Product ID: 54738-908_eb6c8ff1-1c68-444a-b72e-c97b63698ea7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Richmond Pharmaceuticals, Inc.
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54738-908		I	Inactivated by FDA	2026-08-07
excluded package	package	54738-908	54738-908-01	I	Inactivated by FDA	2026-08-07
excluded package	package	54738-908	54738-908-03	I	Inactivated by FDA	2026-08-07

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 · 66 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	54738-908-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54738-908-03	`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	54738-908-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54738-908-03	`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	54738-908-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54738-908-03	`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	54738-908-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54738-908-03	`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	54738-908-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54738-908-03	`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	54738-908-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54738-908-03	`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	54738-908-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54738-908-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54738-908-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54738-908-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54738-908-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54738-908-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54738-908-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54738-908-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54738-908-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54738-908-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54738-908-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54738-908-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54738-908-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54738-908-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54738-908-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54738-908-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54738-908-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54738-908-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54738-908-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54738-908-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54738-908-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54738-908-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54738-908-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54738-908-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54738-908-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54738-908-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54738-908-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54738-908-03	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog.

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
54738-908-01	2019-11-27	C162847	48780-1	9855d018-dbef-cd31-e053-dbdaa90ab51a	CLONIDINE HYDROCHLORIDE TABLETS USP
54738-908-03	2019-11-27	C162847	48780-1	9855d018-dbef-cd31-e053-dbdaa90ab51a	CLONIDINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54738-908-01	Clonidine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		3
54738-908-03	Clonidine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54738-908-01	EA - Each	54738-908	d9f03142-8499-45b6-9f0a-f24341a7ddc2	1	2012-07-24
54738-908-03	EA - Each	54738-908	5c0154b7-6b8f-48ab-93fe-9ea7799235e2	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 [RICHMOND PHARMACEUTICALS, INC.]	3
Clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54738-908	CLONIDINE HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	3	Legacy NDC, 2 package rows	20130314_809d8d33-9459-4e74-8cd2-5f5a9670cb95.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884185	clonidine HCl 200 MCG Oral Tablet	SY	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3
884189	clonidine HCl 300 MCG Oral Tablet	SY	809d8d33-9459-4e74-8cd2-5f5a9670cb95	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54738-908-01	54738090801	100 in 1 BOTTLE, PLASTIC	Historical
54738-908-03	54738090803	1000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE TABLETS USP	Richmond Pharmaceuticals, Inc.	2013-02-06	HUMAN PRESCRIPTION DRUG LABEL	3