FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
70518-3162
11-digit product format
705183162
Labeler code
70518
Product ID
70518-3162_4eca98a9-51c3-f8eb-e063-6394a90a6eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2021-07-19
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
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.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

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
70518-3162-0clonidine hydrochloride30 in 1 BLISTER PACKTABLET3015
70518-3162-1clonidine hydrochloride30 in 1 BLISTER PACKTABLET3015
70518-3162-2clonidine hydrochloride30 in 1 BLISTER PACKTABLET3015
70518-3162-3clonidine hydrochloride100 in 1 BOTTLE, PLASTICTABLET10015
70518-3162-4clonidine hydrochloride180 in 1 BOTTLE, PLASTICTABLET18015
70518-3162-5clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET9015
70518-3162-6clonidine hydrochloride180 in 1 BOTTLE, PLASTICTABLET18015
70518-3162-7clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3162CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 8 package rows20250511_e5d24f52-e0c2-428d-b647-481d63ffd95f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNe5d24f52-e0c2-428d-b647-481d63ffd95f15
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe5d24f52-e0c2-428d-b647-481d63ffd95f15
884173clonidine HCl 100 MCG Oral TabletSYe5d24f52-e0c2-428d-b647-481d63ffd95f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3162-07051831620030 TABLET in 1 BLISTER PACK (70518-3162-0) 30 tablet2021-07-190000-00-00NoNoCurrent
70518-3162-17051831620130 TABLET in 1 BLISTER PACK (70518-3162-1) 30 tablet2023-02-27NoNoHistorical
70518-3162-27051831620230 in 1 BLISTER PACKHistorical
70518-3162-370518316203100 in 1 BOTTLE, PLASTICHistorical
70518-3162-470518316204180 TABLET in 1 BOTTLE, PLASTIC (70518-3162-4) 180 tablet2024-10-15NoNoHistorical
70518-3162-57051831620590 TABLET in 1 BOTTLE, PLASTIC (70518-3162-5) 90 tablet2025-09-12NoNoHistorical
70518-3162-670518316206180 TABLET in 1 BOTTLE, PLASTIC (70518-3162-6) 180 tablet2025-10-31NoNoHistorical
70518-3162-77051831620730 TABLET in 1 BOTTLE, PLASTIC (70518-3162-7) 30 tablet2026-02-01NoNoHistorical