FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
70518-2203
11-digit product format
705182203
Labeler code
70518
Product ID
70518-2203_49dd11b5-ebe1-4e53-e063-6394a90a675a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2019-07-10
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884189

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
70518-2203-0clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET909
70518-2203-1clonidine hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2203CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250309_e96ab74c-eedf-4d71-8a35-d5ec3daa7592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSNe96ab74c-eedf-4d71-8a35-d5ec3daa75929
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe96ab74c-eedf-4d71-8a35-d5ec3daa75929
884189clonidine HCl 300 MCG Oral TabletSYe96ab74c-eedf-4d71-8a35-d5ec3daa75929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-2203-07051822030090 in 1 BOTTLE, PLASTICHistorical
70518-2203-17051822030130 TABLET in 1 BLISTER PACK (70518-2203-1) 30 tablet2023-03-15NoNoHistorical