FDA.reportPublic FDA data

CLONIDINE HYDROCHLORIDE

Product NDC
61919-718
11-digit product format
619190718
Labeler code
61919
Product ID
61919-718_f21551a1-151b-1b6c-e053-2a95a90aa903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA078895
Marketing category
ANDA
Marketing start
2015-01-01
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
2024-12-31
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
61919-718-302025-01-30C16284748780-12cef2736-5b2c-d83d-e063-dadaa90ab31fCLONIDINE HYDROCHLORIDE
61919-718-602025-01-30C16284748780-12cef2736-5b2c-d83d-e063-dadaa90ab31fCLONIDINE HYDROCHLORIDE
61919-718-902025-01-30C16284748780-12cef2736-5b2c-d83d-e063-dadaa90ab31fCLONIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-718-30CLONIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET306
61919-718-60CLONIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET606
61919-718-90CLONIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-718-30EA - Each61919-718c7c9a23d-2614-489a-b303-54c22b828bbf12016-09-02
61919-718-60EA - Each61919-7184a521330-2da6-4795-8b4d-bc5380e78bf712019-08-06
61919-718-90EA - Each61919-718373c97b9-8cb2-445a-9ae4-0e924ba987d312016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-718CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]6Legacy NDC, 3 package rows20230513_4c55668e-8a40-4f07-b60f-5b74c977757b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN4c55668e-8a40-4f07-b60f-5b74c977757b6
884173clonidine hydrochloride 0.1 MG Oral TabletSCD4c55668e-8a40-4f07-b60f-5b74c977757b6
884173clonidine HCl 100 MCG Oral TabletSY4c55668e-8a40-4f07-b60f-5b74c977757b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-718-306191907183030 TABLET in 1 BOTTLE (61919-718-30) 30 tablet2015-12-290000-00-00NoNoCurrent
61919-718-606191907186060 TABLET in 1 BOTTLE (61919-718-60) 60 tablet2015-12-290000-00-00NoNoCurrent
61919-718-906191907189090 TABLET in 1 BOTTLE (61919-718-90) 90 tablet2015-01-010000-00-00NoNoCurrent