FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
50090-1908
Requested package NDC
50090-1908-2
11-digit product format
500901908
Labeler code
50090
Product ID
50090-1908_882a10ae-a951-4823-be71-23bbcc0fed71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-190850090-1908-2DDiscontinued by firm2026-10-05

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078895-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26
A078895-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26
A078895-003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078895-001AB
A078895-002AB
A078895-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078895-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078895-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078895-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078895-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078895-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078895-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078895-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1908-02023-02-07Clonidine Hydrochloride Tablets, USP
50090-1908-12023-02-07Clonidine Hydrochloride Tablets, USP
50090-1908-22023-02-07Clonidine Hydrochloride Tablets, USP
50090-1908-72023-02-07Clonidine Hydrochloride Tablets, USP
50090-1908-82023-02-07Clonidine Hydrochloride Tablets, USP
50090-1908-02023-01-30Clonidine Hydrochloride Tablets, USP
50090-1908-12023-01-30Clonidine Hydrochloride Tablets, USP
50090-1908-22023-01-30Clonidine Hydrochloride Tablets, USP
50090-1908-72023-01-30Clonidine Hydrochloride Tablets, USP
50090-1908-82023-01-30Clonidine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1908-0clonidine hydrochloride30 in 1 BOTTLETABLET3030
50090-1908-1clonidine hydrochloride60 in 1 BOTTLETABLET6030
50090-1908-2clonidine hydrochloride100 in 1 BOTTLETABLET10030
50090-1908-7clonidine hydrochloride90 in 1 BOTTLETABLET9030
50090-1908-8clonidine hydrochloride180 in 1 BOTTLETABLET18030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1908-0EA - Each50090-1908a9b05a76-6ed2-4569-b623-0b1adccfd5f412018-11-06
50090-1908-1EA - Each50090-1908d03f2d37-9adf-44c0-9cd4-a90cb25ecdf712018-09-05
50090-1908-2EA - Each50090-1908aa406217-154c-4334-9055-2f890c795d9112018-09-05
50090-1908-7EA - Each50090-1908b2c1e63d-f3fd-493f-9a05-f1ccb42d1d6812018-09-05
50090-1908-8EA - Each50090-1908fa15f7d8-bd11-4da9-9ba8-5c748ff757df12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1908CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]30Legacy NDC, 5 package rows20240906_70c0c9f4-075d-4621-ae13-e8f03d814d5f.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LPc812012c-4b1d-40a4-8d4e-aaae2bf1c8522019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185cloNIDine HCl 0.2 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189cloNIDine HCl 0.3 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine hydrochloride 0.1 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine hydrochloride 0.2 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine hydrochloride 0.3 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine HCl 100 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine HCl 200 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine HCl 300 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1908-250090190802100 TABLET in 1 BOTTLE (50090-1908-2) 100 tablet2015-06-290000-00-00NoNoCurrent