Clonidine Hydrochloride

Product NDC: 0228-2127
11-digit product format: 002282127
Labeler code: 0228
Product ID: 0228-2127_860129c9-0bba-471e-a90c-b6bede1833b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA070974
Marketing category: ANDA
Marketing start: 1995-01-03
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
A070974-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB		1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070974-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070974-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	1986-12-16	`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	A070974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070974-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070974-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070974-001	AB	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884173	Internal RxNorm lookup
884185	Internal RxNorm lookup
884189	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
a842ab83-3531-44dd-a8a8-64dd89e87026	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
0228-2127-10	Clonidine Hydrochloride	100 in 1 BOTTLE	TABLET	100		18
0228-2127-50	Clonidine Hydrochloride	500 in 1 BOTTLE	TABLET	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2127-10	EA - Each	0228-2127	16a5e27a-ac7b-43e3-a511-247382bf3ae3	1	2012-07-24
0228-2127-50	EA - Each	0228-2127	114663e9-55ac-4061-bd5b-746b5e41bfa9	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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	9
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	7
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	5
Clonidine Hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
Clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [ST MARYS MEDICAL PARK PHARMACY]	3
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE (CLONIDINE HCL) TABLET [STAT RX USA LLC]	2
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE (CLONIDINE HCL) TABLET [STAT RX USA LLC]	2
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [MEDVANTX, INC.]	1
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2127	CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20231216_a842ab83-3531-44dd-a8a8-64dd89e87026.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	7ec53e25-c50a-48b4-82b0-c0b3626f31dc	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Cardinal Health 107, LLC	df62817d-2f50-4c27-aaa8-a22f0290c94f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Northwind Health Company, LLC	66dc3cf0-d6bd-436c-9a7f-7477575b3260	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	BluePoint Laboratories	1ea412db-d847-4094-be83-e3bd7328537a	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	00c6d67a-bb11-4884-9eeb-4e1b8701a08b	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4b087e-a81a-1321-e053-2995a90a2b9f	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cd64137-09d7-7a00-e053-2a91aa0a06ae	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0bde4636-7f34-467e-b9b9-8d281145177d	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	American Health Packaging	b4733c99-656d-4049-9422-3732492dd6ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	a842ab83-3531-44dd-a8a8-64dd89e87026	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070974 application number: ANDA070974 ndc (product): 0228-2127

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	0bde4636-7f34-467e-b9b9-8d281145177d	25
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	0bde4636-7f34-467e-b9b9-8d281145177d	25
884173	clonidine HCl 100 MCG Oral Tablet	SY	0bde4636-7f34-467e-b9b9-8d281145177d	25
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884173	clonidine HCl 100 MCG Oral Tablet	SY	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884185	clonidine HCl 200 MCG Oral Tablet	SY	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884189	clonidine HCl 300 MCG Oral Tablet	SY	a842ab83-3531-44dd-a8a8-64dd89e87026	18
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	9aacff76-c606-45b3-93b5-92eda17303ef	11
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	9aacff76-c606-45b3-93b5-92eda17303ef	11
884173	clonidine HCl 100 MCG Oral Tablet	SY	9aacff76-c606-45b3-93b5-92eda17303ef	11
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6
884173	clonidine HCl 100 MCG Oral Tablet	SY	7cd64137-09d7-7a00-e053-2a91aa0a06ae	6
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	639398cd-3d6a-43d8-93d6-9abecab9d748	5
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	639398cd-3d6a-43d8-93d6-9abecab9d748	5
884173	clonidine HCl 100 MCG Oral Tablet	SY	639398cd-3d6a-43d8-93d6-9abecab9d748	5
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	785f0671-13ba-05f6-e053-2a91aa0a0ec4	4
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	66dc3cf0-d6bd-436c-9a7f-7477575b3260	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	66dc3cf0-d6bd-436c-9a7f-7477575b3260	4
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	785f0671-13ba-05f6-e053-2a91aa0a0ec4	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	66dc3cf0-d6bd-436c-9a7f-7477575b3260	4
884173	clonidine HCl 100 MCG Oral Tablet	SY	785f0671-13ba-05f6-e053-2a91aa0a0ec4	4
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	531eb107-a0bf-4346-946c-18715ca22518	3
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	e6583ff5-0e03-470b-a986-35770aa0e80b	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	531eb107-a0bf-4346-946c-18715ca22518	3
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	e6583ff5-0e03-470b-a986-35770aa0e80b	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	e6583ff5-0e03-470b-a986-35770aa0e80b	3
884173	clonidine HCl 100 MCG Oral Tablet	SY	531eb107-a0bf-4346-946c-18715ca22518	3
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	438dece9-95d4-40f2-84b4-9e2c6d88e760	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	df4b087e-a81a-1321-e053-2995a90a2b9f	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	df4b087e-a81a-1321-e053-2995a90a2b9f	2
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	438dece9-95d4-40f2-84b4-9e2c6d88e760	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	438dece9-95d4-40f2-84b4-9e2c6d88e760	2
884173	clonidine HCl 100 MCG Oral Tablet	SY	df4b087e-a81a-1321-e053-2995a90a2b9f	2
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	5a43b329-7dd6-b479-e053-2991aa0a7d83	1
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	2c04fc9b-5f83-4a3a-87e3-2b07affd0ad0	1
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	c2f1cbfd-54ec-469c-b535-d1df5a11a828	1
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	091a191f-4380-4960-834c-0618da738403	1
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	091a191f-4380-4960-834c-0618da738403	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	c2f1cbfd-54ec-469c-b535-d1df5a11a828	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	2c04fc9b-5f83-4a3a-87e3-2b07affd0ad0	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	091a191f-4380-4960-834c-0618da738403	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	5a43b329-7dd6-b479-e053-2991aa0a7d83	1
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	091a191f-4380-4960-834c-0618da738403	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	c2f1cbfd-54ec-469c-b535-d1df5a11a828	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	091a191f-4380-4960-834c-0618da738403	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	2c04fc9b-5f83-4a3a-87e3-2b07affd0ad0	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	5a43b329-7dd6-b479-e053-2991aa0a7d83	1
884185	clonidine HCl 200 MCG Oral Tablet	SY	091a191f-4380-4960-834c-0618da738403	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2127-10	00228212710	100 TABLET in 1 BOTTLE (0228-2127-10)	100 tablet	1995-01-03	0000-00-00	No	No	Current
0228-2127-50	00228212750	500 TABLET in 1 BOTTLE (0228-2127-50)	500 tablet	1995-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	14
Clonidine Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	19
Clonidine Hydrochloride Tablets, USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
CLONIDINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	2
CLONIDINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals,Inc.	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	6
Clonidine Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-06-11	HUMAN PRESCRIPTION DRUG LABEL	25
Clonidine Hydrochloride Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
CLONIDINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	5
Clonidine Hydrochloride Tablets, USP Rx only	Actavis Pharma, Inc.	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	18
clonidine 0.1mg	RedPharm Drug, Inc.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	4
CLONIDINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2022-01-12	HUMAN PRESCRIPTION DRUG LABEL	5
CLONIDINE HYDROCHLORIDE TABLETS, USP	Major Pharmaceuticals	2020-12-03	HUMAN PRESCRIPTION DRUG LABEL	12
CLONIDINE HYDROCHLORIDE TABLETS, USP	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2020-11-10	HUMAN PRESCRIPTION DRUG LABEL	9
CLONIDINE HYDROCHLORIDE	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
CLONIDINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
CLONIDINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2019-08-07	HUMAN PRESCRIPTION DRUG LABEL	9
CLONIDINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	11
CLONIDINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine HCL	St Marys Medical Park Pharmacy \| Actavis Elizabeth LLC	2018-11-12	HUMAN PRESCRIPTION DRUG LABEL	6
094 Clonidine 0.1 mg CLONIDINE HYDROCHLORIDE TABLETS, USP	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-09-28	HUMAN PRESCRIPTION DRUG LABEL	1
CLONIDINE HYDROCHLORIDE TABLETS, USP 40-9009 Revised — May 2010 Rx only	MedVantx, Inc. \| Actavis Elizabeth LLC \| Blenheim Pharmacal, Inc.	2010-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
CLONIDINE HYDROCHLORIDE TABLETS, USP Rx only	State of Florida DOH Central Pharmacy	2010-05-21	HUMAN PRESCRIPTION DRUG LABEL	1
CLONIDINE - STAT RX USA LLC	STAT RX USA LLC	2010-03-15	HUMAN PRESCRIPTION DRUG LABEL	2