CLONIDINE HYDROCHLORIDE

Product NDC: 63187-202
Requested package NDC: 63187-202-60
11-digit product format: 631870202
Labeler code: 63187
Product ID: 63187-202_e3d8d1b7-c75d-4d98-850c-e568c842ae78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA070925
Marketing category: ANDA
Marketing start: 1987-09-04
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: 2026-12-31
Current FDA listing: Yes

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 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: CLONIDINE HYDROCHLORIDE
Listing expiration: 2026-12-31

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
d072d601-b3d2-46e0-af1f-98adc9572f4a	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63187-202-30	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-30	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-60	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-60	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-90	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-90	2025-10-30	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-30	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-30	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-60	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-60	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-90	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP
63187-202-90	2021-01-29	CLONIDINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-202-30	CLONIDINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET	30	4
63187-202-60	CLONIDINE HYDROCHLORIDE	60 in 1 BOTTLE, PLASTIC	TABLET	60	4
63187-202-90	CLONIDINE HYDROCHLORIDE	90 in 1 BOTTLE, PLASTIC	TABLET	90	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clonidine hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-202	CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20190130_d072d601-b3d2-46e0-af1f-98adc9572f4a.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
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 ndc (package): 63187-202-60 ndc (product): 63187-202 ndc11 (package): 63187020260
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	d072d601-b3d2-46e0-af1f-98adc9572f4a	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	d072d601-b3d2-46e0-af1f-98adc9572f4a	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	d072d601-b3d2-46e0-af1f-98adc9572f4a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63187-202-60	63187020260	60 TABLET in 1 BOTTLE, PLASTIC (63187-202-60)	60 tablet	2015-02-02	No	No	Current