Clonidine hydrochloride

Product NDC: 60687-462
11-digit product format: 606870462
Labeler code: 60687
Product ID: 60687-462_1a9e9967-92e8-a001-e063-6394a90a0204
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA209686
Marketing category: ANDA
Marketing start: 2019-12-17
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209686-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209686-001	AB1

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2017-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209686-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2017-11-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209686-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209686-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209686-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209686-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209686-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209686-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209686-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209686-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209686-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209686-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209686-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209686-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209686-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209686-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209686-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209686-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209686-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209686-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209686-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209686-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209686-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209686-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209686-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209686-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209686-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209686-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209686-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209686-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209686-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209686-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209686-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209686-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209686-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209686-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209686-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209686-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209686-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209686-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209686-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209686-001	AB1	1	`cb3db0bc1861…`

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
1013930	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
95b390cc-0578-4cb0-9c08-4853388b2ec9	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	Strength	SPL version
60687-462-11	Clonidine hydrochloride	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		4
60687-462-21	Clonidine hydrochloride	30 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-462-11	EA - Each	60687-462	03319089-b97b-4675-a06f-898e8846a8e3	1	2019-12-10
60687-462-21	EA - Each	60687-462	01f69583-8598-4ee0-911e-0699d4d13a53	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-462	CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4	Current NDC, Legacy NDC, 2 package rows	20240612_95b390cc-0578-4cb0-9c08-4853388b2ec9.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
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	df80255e-f942-4d9f-8edd-cc95795772cb	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	f34ae077-4ace-4e0a-bc87-d559b1c5bf2f	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686
Clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	95b390cc-0578-4cb0-9c08-4853388b2ec9	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209686 application number: ANDA209686 ndc (product): 60687-462

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
1013930	cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet	PSN	95b390cc-0578-4cb0-9c08-4853388b2ec9	4
1013930	12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet	SCD	95b390cc-0578-4cb0-9c08-4853388b2ec9	4
1013930	clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet	SY	95b390cc-0578-4cb0-9c08-4853388b2ec9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-462-11	60687046211	1 in 1 BLISTER PACK						Historical
60687-462-21	60687046221	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-462-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-462-11)	30 blister pack	2019-12-17	0000-00-00	No	No	Current