Clonidine Hydrochloride

Product NDC: 58657-648
Requested package NDC: 58657-648-50
11-digit product format: 586570648
Labeler code: 58657
Product ID: 58657-648_2ea9750b-e90d-cc5b-e063-6394a90a7e78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: ANDA202297
Marketing category: ANDA
Marketing start: 2020-07-01
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202297-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13
A202297-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13
A202297-003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202297-001	AB
A202297-002	AB
A202297-003	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	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`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	A202297-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202297-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202297-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202297-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202297-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202297-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202297-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202297-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202297-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202297-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202297-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202297-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202297-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202297-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202297-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202297-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202297-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202297-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202297-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202297-001	AB	1	`8072bd15b7f6…`

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	.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 · 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
dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	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
58657-648-01	Clonidine Hydrochloride	100 in 1 BOTTLE	TABLET	100	7
58657-648-10	Clonidine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	7
58657-648-50	Clonidine Hydrochloride	500 in 1 BOTTLE	TABLET	500	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-648-01	EA - Each	58657-648	a13b5a9e-c63b-4ad5-8042-803941226116	1	2020-09-14
58657-648-10	EA - Each	58657-648	0623b271-6fb4-442d-bf75-a24d09676229	1	2022-05-04
58657-648-50	EA - Each	58657-648	1eeb28bc-21d5-4433-a562-0b5a6e8726d9	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-648	CLONIDINE HYDROCHLORIDE TABLET [METHOD PHARMACEUTICALS, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250223_dffb5fdd-06c0-4275-9f89-9e12b3adf8a9.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	e413efdf-980b-4b33-80f1-5be899a10f01	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	60171b1d-03af-4849-a030-6260192b11ce	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	5bc6188d-5b51-4dee-a12d-f2d5e42eb88d	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	REMEDYREPACK INC.	6d7cfb02-e580-4658-a2fe-2149b515d434	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Coupler LLC	325f382b-6c04-2608-e063-6394a90a3872	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	122f6904-bb63-42c5-b000-f4f5c75586cc	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	d2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	075b6261-9064-41da-b5e0-0959767e0d9a	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	029ed62c-67cb-406f-84e4-702aebfa7d68	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	74b40ae9-a9d7-443e-8d7a-80362ec5be6d	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	6c95c495-f630-45c1-92c3-8c0fdb22013c	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297 ndc (package): 58657-648-50 ndc (product): 58657-648 ndc11 (package): 58657064850
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	d3b099db-698e-4ea8-a6df-42dc79234597	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	0f8adf88-26a4-4dd1-bfbb-784a528641e6	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	1c65bafb-9752-4785-84b1-376cf863fd07	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	1df79865-c028-45c7-8580-9908eec80979	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	849cafb5-0a98-4434-80bb-b16e7109dd06	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297
Clonidine Hydrochloride	CLONIDINE HYDROCHLORIDE	Bryant Ranch Prepack	88c11229-7eed-4fed-983f-503b78f03383	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202297 application number: ANDA202297

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	74b40ae9-a9d7-443e-8d7a-80362ec5be6d	107
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	74b40ae9-a9d7-443e-8d7a-80362ec5be6d	107
884185	clonidine HCl 200 MCG Oral Tablet	SY	74b40ae9-a9d7-443e-8d7a-80362ec5be6d	107
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	6c95c495-f630-45c1-92c3-8c0fdb22013c	106
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	6c95c495-f630-45c1-92c3-8c0fdb22013c	106
884185	clonidine HCl 200 MCG Oral Tablet	SY	6c95c495-f630-45c1-92c3-8c0fdb22013c	106
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	122f6904-bb63-42c5-b000-f4f5c75586cc	104
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	122f6904-bb63-42c5-b000-f4f5c75586cc	104
884185	clonidine HCl 200 MCG Oral Tablet	SY	122f6904-bb63-42c5-b000-f4f5c75586cc	104
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	d3b099db-698e-4ea8-a6df-42dc79234597	103
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	d3b099db-698e-4ea8-a6df-42dc79234597	103
884185	clonidine HCl 200 MCG Oral Tablet	SY	d3b099db-698e-4ea8-a6df-42dc79234597	103
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	e413efdf-980b-4b33-80f1-5be899a10f01	7
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	e413efdf-980b-4b33-80f1-5be899a10f01	7
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884173	clonidine HCl 100 MCG Oral Tablet	SY	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884185	clonidine HCl 200 MCG Oral Tablet	SY	e413efdf-980b-4b33-80f1-5be899a10f01	7
884185	clonidine HCl 200 MCG Oral Tablet	SY	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884189	clonidine HCl 300 MCG Oral Tablet	SY	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	325f382b-6c04-2608-e063-6394a90a3872	1
884185	cloNIDine HCl 0.2 MG Oral Tablet	PSN	5bc6188d-5b51-4dee-a12d-f2d5e42eb88d	1
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	325f382b-6c04-2608-e063-6394a90a3872	1
884185	clonidine hydrochloride 0.2 MG Oral Tablet	SCD	5bc6188d-5b51-4dee-a12d-f2d5e42eb88d	1
884185	clonidine HCl 200 MCG Oral Tablet	SY	325f382b-6c04-2608-e063-6394a90a3872	1
884185	clonidine HCl 200 MCG Oral Tablet	SY	5bc6188d-5b51-4dee-a12d-f2d5e42eb88d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-648-50	58657064850	500 TABLET in 1 BOTTLE (58657-648-50)	500 tablet	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets	REMEDYREPACK INC.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	7
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine Hydrochloride Tablets	Coupler LLC	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	104
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	107
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	106
Clonidine Hydrochloride Tablets	Method Pharmaceuticals, LLC	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	7
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	103