FDA.reportPublic FDA data

CLONIDINE HYDROCHLORIDE

Product NDC
61919-605
11-digit product format
619190605
Labeler code
61919
Product ID
61919-605_0e883a0f-ef15-109e-e063-6294a90aa908
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA091368
Marketing category
ANDA
Marketing start
2019-04-04
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLONIDINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884189

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-605-30CLONIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
61919-605-60CLONIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET604
61919-605-90CLONIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-605CLONIDINE HYDROCHLORIDE TABLET [DIRECTRX]4Current NDC, Legacy NDC, 3 package rows20240110_2823a922-3217-6062-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884189cloNIDine HCl 0.3 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884189clonidine hydrochloride 0.3 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884173clonidine HCl 100 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884
884189clonidine HCl 300 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-605-306191906053030 TABLET in 1 BOTTLE (61919-605-30) 30 tablet2019-04-040000-00-00NoNoCurrent
61919-605-606191906056060 TABLET in 1 BOTTLE (61919-605-60) 60 tablet2019-04-040000-00-00NoNoCurrent
61919-605-906191906059090 TABLET in 1 BOTTLE (61919-605-90) 90 tablet2019-04-040000-00-00NoNoCurrent