Clonidine Hydrochloride

Product NDC: 61442-322
11-digit product format: 614420322
Labeler code: 61442
Product ID: 61442-322_1b1643e8-8b55-404d-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Carlsbad Technology, Inc
Application: ANDA202297
Marketing category: ANDA
Marketing start: 2013-06-17
Marketing end: 0000-00-00
Substance: CLONIDINE HYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61442-322		D	Discontinued by firm	2026-08-03
excluded package	package	61442-322	61442-322-01	D	Discontinued by firm	2026-08-03
excluded package	package	61442-322	61442-322-05	D	Discontinued by firm	2026-08-03
excluded package	package	61442-322	61442-322-10	D	Discontinued by firm	2026-08-03

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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-322-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-322-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-322-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-322-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-322-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-322-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-322-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-322-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-322-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-322-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-322-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-322-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-322-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-322-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-322-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-322-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-322-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-322-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-322-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-322-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-322-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-322-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-322-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-322-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-322-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-322-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-322-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-322-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-322-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-322-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-322-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-322-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-322-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-322-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-322-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-322-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-322-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-322-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-322-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-322-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-322-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-322-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-322-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-322-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-322-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-322-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-322-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-322-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61442-322-01	2026-01-14	Clonidine Hydrochloride Tablets, USP
61442-322-05	2026-01-14	Clonidine Hydrochloride Tablets, USP
61442-322-10	2026-01-14	Clonidine Hydrochloride Tablets, USP
61442-322-30	2026-01-14	Clonidine Hydrochloride Tablets, USP
61442-322-01	2020-01-31	Clonidine Hydrochloride Tablets, USP
61442-322-05	2020-01-31	Clonidine Hydrochloride Tablets, USP
61442-322-10	2020-01-31	Clonidine Hydrochloride Tablets, USP
61442-322-30	2020-01-31	Clonidine Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61442-322-01	EA - Each	61442-322	66fc2797-c9cd-401a-9e4f-8bcec3f5de3f	1	2013-10-17
61442-322-05	EA - Each	61442-322	db9d1394-bbf7-4307-9bea-f06d9a1bfa22	1	2013-10-17
61442-322-10	EA - Each	61442-322	8f8a24c4-0d41-49e5-b16d-a4e928c45b55	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3
Clonidine Hydrochloride	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Clonidine	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61442-322	CLONIDINE HYDROCHLORIDE TABLET [CARLSBAD TECHNOLOGY, INC]	3	Legacy NDC	20150717_f2c4a60b-079f-418b-8ed4-6a44de77ad51.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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets, USP	Golden State Medical Supply, Inc.	2018-12-10	HUMAN PRESCRIPTION DRUG LABEL	4
Clonidine Hydrochloride Tablets, USP	A-S Medication Solutions	2017-09-07	HUMAN PRESCRIPTION DRUG LABEL	6
Clonidine Hydrochloride Tablets, USP	Carlsbad Technology, Inc \| Yung Shin Pharmaceutical Industrial Co., Ltd.	2015-07-17	HUMAN PRESCRIPTION DRUG LABEL	3