Clonidine Hydrochloride

Product NDC: 68071-2631
11-digit product format: 680712631
Labeler code: 68071
Product ID: 68071-2631_d6f7e170-858d-9134-e053-2a95a90aac6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202297
Marketing category: ANDA
Marketing start: 2020-07-01
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: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2631		I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2631	68071-2631-2	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2631	68071-2631-3	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2631	68071-2631-5	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2631	68071-2631-6	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2631	68071-2631-9	I	Inactivated by FDA	2026-08-17

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2631-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2631-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2631-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2631-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2631-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2631-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2631-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2631-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2631-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2631-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2631-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2631-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2631-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2631-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2631-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2631-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2631-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2631-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2631-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2631-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2631-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2631-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2631-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2631-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2631-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2631-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2631-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2631-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2631-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2631-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2631-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2631-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2631-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2631-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2631-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2631-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2631-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2631-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2631-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2631-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2631-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2631-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2631-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2631-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2631-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	A202297-001	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET / ORAL	AB	2013-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202297-002	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET / ORAL	AB	2013-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202297-003	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET / ORAL	AB	2013-06-13	`caaa826d4ba7…`
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…`

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	A202297-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202297-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202297-003	AB	1	`caaa826d4ba7…`
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68071-2631-2	Clonidine Hydrochloride Tablets
68071-2631-3	Clonidine Hydrochloride Tablets
68071-2631-5	Clonidine Hydrochloride Tablets
68071-2631-6	Clonidine Hydrochloride Tablets
68071-2631-9	Clonidine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2631-2	Clonidine Hydrochloride	120 in 1 BOTTLE	TABLET	120	1
68071-2631-3	Clonidine Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
68071-2631-5	Clonidine Hydrochloride	15 in 1 BOTTLE	TABLET	15	1
68071-2631-6	Clonidine Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
68071-2631-9	Clonidine Hydrochloride	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2631	CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 5 package rows	20220202_d6f7ebb0-e05e-d382-e053-2a95a90a39f2.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884173	cloNIDine HCl 0.1 MG Oral Tablet	PSN	d6f7ebb0-e05e-d382-e053-2a95a90a39f2	1
884173	clonidine hydrochloride 0.1 MG Oral Tablet	SCD	d6f7ebb0-e05e-d382-e053-2a95a90a39f2	1
884173	clonidine HCl 100 MCG Oral Tablet	SY	d6f7ebb0-e05e-d382-e053-2a95a90a39f2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2631-2	68071263102	120 TABLET in 1 BOTTLE (68071-2631-2)	120 tablet	2022-02-01	0000-00-00	No	No	Current
68071-2631-3	68071263103	30 TABLET in 1 BOTTLE (68071-2631-3)	30 tablet	2022-02-01	0000-00-00	No	No	Current
68071-2631-5	68071263105	15 TABLET in 1 BOTTLE (68071-2631-5)	15 tablet	2022-02-01	0000-00-00	No	No	Current
68071-2631-6	68071263106	60 TABLET in 1 BOTTLE (68071-2631-6)	60 tablet	2022-02-01	0000-00-00	No	No	Current
68071-2631-9	68071263109	90 TABLET in 1 BOTTLE (68071-2631-9)	90 tablet	2022-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonidine Hydrochloride Tablets	NuCare Pharmaceuticals,Inc.	2022-02-01	HUMAN PRESCRIPTION DRUG LABEL	1