Clonidine Hydrochloride

Product NDC
55289-073
11-digit product format
552890073
Labeler code
55289
Product ID
55289-073_7aba96aa-f7fa-1ce3-e053-2a91aa0a6405
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA070317
Marketing category
ANDA
Marketing start
1987-06-09
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-073DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-01DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-08DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-15DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-20DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-30DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-60DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-90DDiscontinued by firm2026-08-03
excluded packagepackage55289-07355289-073-93DDiscontinued by firm2026-08-03

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 · 108 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-073-93d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55289-073-93f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55289-073-932ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55289-073-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55289-073-93cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55289-073-93cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-073-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-073-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-073-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-073-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55289-073-20302b2466d912…e7b80fea0513…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070317-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09
A070317-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09
A070317-003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070317-002CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORAL1987-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070317-003CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORAL1987-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070317-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORAL1987-06-098072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A070317-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070317-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070317-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A070317-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A070317-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A070317-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070317-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A070317-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A070317-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070317-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A070317-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A070317-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-073-01EA - Each55289-07379a855fb-18c1-4b4a-a46b-3a672986b3c712012-07-24
55289-073-08EA - Each55289-073b8f5d6fa-b0a3-429c-9c2e-c53d49f167bf12012-07-24
55289-073-15EA - Each55289-0739c6a6c27-558a-4d8f-8339-fe3f9c9b532312016-05-16
55289-073-20EA - Each55289-07366f24956-584d-4a94-a8a1-fa6dbd4467b612012-07-24
55289-073-30EA - Each55289-073220791e4-fcc8-4051-94ee-9270f4ceebc812012-07-24
55289-073-60EA - Each55289-073819e51d8-07fb-41b7-b66c-d2d45cf6fb6b12012-07-24
55289-073-90EA - Each55289-0735ed9c67b-9994-47fa-98c5-55558189b13012012-07-24
55289-073-93EA - Each55289-07360fd282c-8e0d-45da-820c-642e8434804a12012-07-24