Clonidine Hydrochloride

Product NDC
51079-299
11-digit product format
510790299
Labeler code
51079
Product ID
51079-299_9a250335-e14c-c9ad-e053-2a95a90a08c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070317
Marketing category
ANDA
Marketing start
1997-02-14
Marketing end
2020-09-30
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
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51079-299DDiscontinued by firm2026-08-03
excluded packagepackage51079-29951079-299-20DDiscontinued 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 1 · 24 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 packagepackage51079-299-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51079-299-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51079-299-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51079-299-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51079-299-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51079-299-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51079-299-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51079-299-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51079-299-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51079-299-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51079-299-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51079-299-20557ba5c1ecfa…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-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
51079-299-01EA - Each51079-299dd4e5bf8-1785-4628-8d0b-a83e716704f812012-07-24
51079-299-17EA - Each51079-299758e32ec-4fe3-433f-b6eb-669db34e9bea12012-07-24
51079-299-19EA - Each51079-2996f6b2344-443a-49db-89b1-3e76ed7a24d712012-07-24
51079-299-20EA - Each51079-2994f10e9e2-2473-4065-b1ab-7eaa443e120d12012-07-24
51079-299-66EA - Each51079-299df53011f-60d6-4634-8f4d-677625f6fcd112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DCLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLONIDINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]5