Clonidine Hydrochloride

Product NDC: 58657-649
Requested package NDC: 58657-649-01
11-digit product format: 586570649
Labeler code: 58657
Product ID: 58657-649_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: .3 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 58657-649-01 ndc (product): 58657-649 ndc11 (package): 58657064901
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

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	.3 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
58657-649-01	Clonidine Hydrochloride	100 in 1 BOTTLE	TABLET	100	7
58657-649-10	Clonidine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	7
58657-649-50	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
58657-649-01	EA - Each	58657-649	a0c21ad9-f9fd-4144-b9eb-b51357b9aa5f	1	2020-09-14
58657-649-10	EA - Each	58657-649	e067e2af-0bdf-4be4-b166-ff39db978ab3	1	2022-05-04
58657-649-50	EA - Each	58657-649	83b6e659-0b65-49e7-814f-ac3304a0f01f	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-649	CLONIDINE HYDROCHLORIDE TABLET [METHOD PHARMACEUTICALS, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250223_dffb5fdd-06c0-4275-9f89-9e12b3adf8a9.zip

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
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	1df79865-c028-45c7-8580-9908eec80979	107
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	1df79865-c028-45c7-8580-9908eec80979	107
884189	clonidine HCl 300 MCG Oral Tablet	SY	1df79865-c028-45c7-8580-9908eec80979	107
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	029ed62c-67cb-406f-84e4-702aebfa7d68	106
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	029ed62c-67cb-406f-84e4-702aebfa7d68	106
884189	clonidine HCl 300 MCG Oral Tablet	SY	029ed62c-67cb-406f-84e4-702aebfa7d68	106
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	849cafb5-0a98-4434-80bb-b16e7109dd06	105
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	849cafb5-0a98-4434-80bb-b16e7109dd06	105
884189	clonidine HCl 300 MCG Oral Tablet	SY	849cafb5-0a98-4434-80bb-b16e7109dd06	105
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	075b6261-9064-41da-b5e0-0959767e0d9a	102
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	075b6261-9064-41da-b5e0-0959767e0d9a	102
884189	clonidine HCl 300 MCG Oral Tablet	SY	075b6261-9064-41da-b5e0-0959767e0d9a	102
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	60171b1d-03af-4849-a030-6260192b11ce	100
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	60171b1d-03af-4849-a030-6260192b11ce	100
884189	clonidine HCl 300 MCG Oral Tablet	SY	60171b1d-03af-4849-a030-6260192b11ce	100
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	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	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	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884189	clonidine HCl 300 MCG Oral Tablet	SY	dffb5fdd-06c0-4275-9f89-9e12b3adf8a9	7
884189	cloNIDine HCl 0.3 MG Oral Tablet	PSN	6d7cfb02-e580-4658-a2fe-2149b515d434	1
884189	clonidine hydrochloride 0.3 MG Oral Tablet	SCD	6d7cfb02-e580-4658-a2fe-2149b515d434	1
884189	clonidine HCl 300 MCG Oral Tablet	SY	6d7cfb02-e580-4658-a2fe-2149b515d434	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-649-01	58657064901	100 TABLET in 1 BOTTLE (58657-649-01)	100 tablet	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	100
Clonidine Hydrochloride Tablets	REMEDYREPACK INC.	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	102
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	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	107
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	105
Clonidine Hydrochloride Tablets	Bryant Ranch Prepack	2022-06-06	HUMAN PRESCRIPTION DRUG LABEL	100