clonidine hydrochloride

Product NDC: 68788-8080
Requested package NDC: 68788-8080-9
11-digit product format: 687888080
Labeler code: 68788
Product ID: 68788-8080_d3ec9424-482b-4948-8e5e-bb48ac4bca49
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA091368
Marketing category: ANDA
Marketing start: 2021-10-05
Substance: CLONIDINE HYDROCHLORIDE
Active strength: .2 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-8080	68788-8080-9	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091368-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06
A091368-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06
A091368-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091368-001	AB
A091368-002	AB
A091368-003	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 4 · 123 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	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091368-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091368-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091368-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091368-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091368-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091368-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091368-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091368-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091368-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091368-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091368-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091368-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091368-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091368-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091368-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091368-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091368-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: clonidine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONIDINE HYDROCHLORIDE	.2 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
884185	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
770b56aa-fcf3-4327-98d1-d87e5a037234	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	SPL version
68788-8080-3	clonidine hydrochloride	30 in 1 BOTTLE	TABLET	30	5
68788-8080-6	clonidine hydrochloride	60 in 1 BOTTLE	TABLET	60	5
68788-8080-9	clonidine hydrochloride	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8080-3	EA - Each	68788-8080	ac08eb76-51de-4c36-9b20-078f718ab3f4	1	2021-11-09
68788-8080-6	EA - Each	68788-8080	6b68b3a1-d69e-46a4-8ba7-b0124049ab91	1	2021-11-09
68788-8080-9	EA - Each	68788-8080	502e9b94-159d-4b15-9b3f-c6ed39f798bf	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8080	CLONIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250112_770b56aa-fcf3-4327-98d1-d87e5a037234.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	574640a5-829d-4e9d-be32-832a48cbd8dd	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	2a183d05-5be7-43e9-a084-700ec05d01e9	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	666e757e-9b43-2e40-e053-2991aa0a59a2	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	56a80e79-9cfe-4361-a90a-9245632efa05	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	770b56aa-fcf3-4327-98d1-d87e5a037234	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368 ndc (package): 68788-8080-9 ndc (product): 68788-8080 ndc11 (package): 68788808009
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	VERITYRX, LLC	42788adf-a54d-3545-e063-6394a90a8c69	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	746dcdfd-7dfb-4a29-e053-2991aa0a8a4c	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	100a31f2-9a8e-4245-a09c-05583c3244c3	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	1c13555e-acfc-4a3a-93cd-e6f012f36c61	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5366a055-47fd-41eb-81d8-ffb3be1dc38c	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	61b56917-1442-4068-86d8-0e5a5a59e612	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	329382fb-ccf8-488d-a0b2-68ff959a0846	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	A-S Medication Solutions	aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	be6c29cd-1692-4dd3-868e-7efcb3a85056	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a9de8b29-5cd2-a49d-e053-2995a90a4f0e	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	DirectRX	2823a922-3217-6062-e054-00144ff88e88	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	88a8db46-0fc9-48cd-b7cc-ac9c9cdea100	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Asclemed USA, Inc.	b60034a6-b8ba-4e54-9ef0-029965e67bc0	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368

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
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	770b56aa-fcf3-4327-98d1-d87e5a037234	5
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	770b56aa-fcf3-4327-98d1-d87e5a037234	5
884185	clonidine HCl 200 MCG Oral Tablet	SY	770b56aa-fcf3-4327-98d1-d87e5a037234	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8080-9	68788808009	90 TABLET in 1 BOTTLE (68788-8080-9)	90 tablet	2021-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clonidine hydrochloride	Preferred Pharmaceuticals Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	5