FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
70518-3295
11-digit product format
705183295
Labeler code
70518
Product ID
70518-3295_4ef212c8-6f0f-e9c2-e063-6294a90a4f25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202297
Marketing category
ANDA
Marketing start
2021-12-14
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 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.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884185

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
70518-3295-0Clonidine Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3295-1Clonidine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3295CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20250507_e413efdf-980b-4b33-80f1-5be899a10f01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSNe413efdf-980b-4b33-80f1-5be899a10f017
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe413efdf-980b-4b33-80f1-5be899a10f017
884185clonidine HCl 200 MCG Oral TabletSYe413efdf-980b-4b33-80f1-5be899a10f017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3295-07051832950030 TABLET in 1 BLISTER PACK (70518-3295-0) 30 tablet2021-12-140000-00-00NoNoCurrent
70518-3295-170518329501180 TABLET in 1 BOTTLE, PLASTIC (70518-3295-1) 180 tablet2025-06-30NoNoCurrent