FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
50090-5103
11-digit product format
500905103
Labeler code
50090
Product ID
50090-5103_92366bc8-b474-4137-8a14-1a57617bfa3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070974
Marketing category
ANDA
Marketing start
1995-01-03
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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5103-02024-01-30C16284748780-11030e365-0372-111a-e063-dadaa90a10e2CLONIDINE HYDROCHLORIDE TABLETS, USP
50090-5103-12024-01-30C16284748780-11030e365-0372-111a-e063-dadaa90a10e2CLONIDINE HYDROCHLORIDE TABLETS, USP
50090-5103-22024-01-30C16284748780-11030e365-0372-111a-e063-dadaa90a10e2CLONIDINE HYDROCHLORIDE TABLETS, USP
50090-5103-72024-01-30C16284748780-11030e365-0372-111a-e063-dadaa90a10e2CLONIDINE HYDROCHLORIDE TABLETS, USP
50090-5103-82024-01-30C16284748780-11030e365-0372-111a-e063-dadaa90a10e2CLONIDINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5103-0Clonidine Hydrochloride30 in 1 BOTTLETABLET305
50090-5103-1Clonidine Hydrochloride60 in 1 BOTTLETABLET605
50090-5103-2Clonidine Hydrochloride100 in 1 BOTTLETABLET1005
50090-5103-7Clonidine Hydrochloride90 in 1 BOTTLETABLET905
50090-5103-8Clonidine Hydrochloride180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5103CLONIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 5 package rows20220113_639398cd-3d6a-43d8-93d6-9abecab9d748.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN639398cd-3d6a-43d8-93d6-9abecab9d7485
884173clonidine hydrochloride 0.1 MG Oral TabletSCD639398cd-3d6a-43d8-93d6-9abecab9d7485
884173clonidine HCl 100 MCG Oral TabletSY639398cd-3d6a-43d8-93d6-9abecab9d7485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5103-05009051030030 TABLET in 1 BOTTLE (50090-5103-0) 30 tablet2020-07-170000-00-00NoNoCurrent
50090-5103-15009051030160 TABLET in 1 BOTTLE (50090-5103-1) 60 tablet2020-07-170000-00-00NoNoCurrent
50090-5103-250090510302100 TABLET in 1 BOTTLE (50090-5103-2) 100 tablet2020-07-170000-00-00NoNoCurrent
50090-5103-75009051030790 TABLET in 1 BOTTLE (50090-5103-7) 90 tablet2020-07-170000-00-00NoNoCurrent
50090-5103-850090510308180 TABLET in 1 BOTTLE (50090-5103-8) 180 tablet2020-07-170000-00-00NoNoCurrent