Clonidine

Product NDC: 52817-375
11-digit product format: 528170375
Labeler code: 52817
Product ID: 52817-375_0eb6d1fe-949a-312a-e063-6294a90ae10c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TruPharma, LLC
Application: NDA022500
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-01-11
Substance: CLONIDINE
Active strength: .17 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022500-001	NEXICLON XR	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL			2009-12-03
N022500-002	NEXICLON XR	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL			2009-12-03

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022500-001	8337890	2027-04-17	Drug product	2020-07-01
N022500-001	8623409	2031-09-08	Drug product	2020-07-01
N022500-002	8337890	2027-04-17	Drug product	2020-07-01
N022500-002	8623409	2031-09-08	Drug product	2020-07-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022500-001	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022500-002	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022500-001	NEXICLON XR	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022500-002	NEXICLON XR	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE / ORAL	2009-12-03	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-001	8337890	2027-04-17	Drug product	2020-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-001	8623409	2031-09-08	Drug product	2020-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-002	8337890	2027-04-17	Drug product	2020-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022500-002	8623409	2031-09-08	Drug product	2020-07-01	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE	.17 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MN3L5RMN02	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
885880	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
2311836b-de63-4e8c-a021-600c40110024	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
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
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
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52817-375-30	Clonidine	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-375-30	EA - Each	52817-375	34f5d8cc-3974-41c5-b150-6cd474736f74	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-375	CLONIDINE TABLET, EXTENDED RELEASE [TRUPHARMA, LLC]	1	Current NDC, 1 package rows	20240113_2311836b-de63-4e8c-a021-600c40110024.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexiclon XR	CLONIDINE	Rosemont Pharmaceuticals LLC	dad35a6f-d57e-f302-e053-2995a90a9efb	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500
Clonidine	CLONIDINE	TruPharma, LLC	2311836b-de63-4e8c-a021-600c40110024	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500 ndc (product): 52817-375
Clonidine	CLONIDINE	PALMETTO PHARMACEUTICALS INC.	e93324f1-ad83-7bbe-e053-2995a90a8c9e	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022500 application number: NDA022500

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MN3L5RMN02	CLONIDINE	4205-90-7	CLONIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885880	cloNIDine 0.17 MG 24HR Extended Release Oral Tablet	PSN	2311836b-de63-4e8c-a021-600c40110024	1
885880	24 HR clonidine 0.17 MG Extended Release Oral Tablet	SCD	2311836b-de63-4e8c-a021-600c40110024	1
885880	clonidine 0.17 MG (equivalent to clonidine HCl 0.2 MG) 24 HR Extended Release Oral Tablet	SY	2311836b-de63-4e8c-a021-600c40110024	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
52817-375-30	52817037530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30)	2024-01-11	No	No	Current