clonidine hydrochloride

Product NDC: 83939-0005
11-digit product format: 839390005
Labeler code: 83939
Product ID: 83939-0005_42788b2f-2fbc-d9f8-e063-6294a90aa08e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: VERITYRX, LLC
Application: ANDA091368
Marketing category: ANDA
Marketing start: 2016-05-03
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 42.

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 · 126 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
2026-08-18 06:07:40	2026-07	A091368-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2011-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091368-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2011-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091368-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2011-12-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091368-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091368-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091368-003	AB	1	`caaa826d4ba7…`
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…`

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
42788adf-a54d-3545-e063-6394a90a8c69	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
83939-0005-1	clonidine hydrochloride	1 in 1 POUCH	TABLET	1	1
83939-0005-2	clonidine hydrochloride	1 in 1 POUCH	TABLET	1	1
83939-0005-2	clonidine hydrochloride	50 in 1 BOX, UNIT-DOSE	TABLET	50	1
83939-0005-3	clonidine hydrochloride	100 in 1 BOX, UNIT-DOSE	TABLET	100	1
83939-0005-3	clonidine hydrochloride	1 in 1 POUCH	TABLET	1	1

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	58772b44-dec0-7001-e063-6394a90ac40e	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
clonidine hydrochloride	CLONIDINE HYDROCHLORIDE	Redpharm Drug	53df40e7-dd2b-d40e-e063-6394a90a21c4	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091368 application number: ANDA091368
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	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
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 ndc (product): 83939-0005
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

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	42788adf-a54d-3545-e063-6394a90a8c69	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	42788adf-a54d-3545-e063-6394a90a8c69	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	42788adf-a54d-3545-e063-6394a90a8c69	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83939-0005-1	83939000501	1 TABLET in 1 POUCH (83939-0005-1)	1 tablet	2025-11-03	No	No	Current
83939-0005-2	83939000502	50 POUCH in 1 BOX, UNIT-DOSE (83939-0005-2) / 1 TABLET in 1 POUCH	50 pouch	2025-11-03	No	No	Current
83939-0005-3	83939000503	100 POUCH in 1 BOX, UNIT-DOSE (83939-0005-3) / 1 TABLET in 1 POUCH	100 pouch	2025-11-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP 0.1MG Oral Antihypertensive Rx only	VERITYRX, LLC	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	1