FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
76420-285
11-digit product format
764200285
Labeler code
76420
Product ID
76420-285_e8c7a94e-8d26-886a-e053-2995a90a1ad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA070924
Marketing category
ANDA
Marketing start
2017-06-01
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
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.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884185, 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
76420-285-01Clonidine hydrochloride100 in 1 BOTTLETABLET1001
76420-285-20Clonidine hydrochloride20 in 1 BOTTLETABLET201
76420-285-30Clonidine hydrochloride30 in 1 BOTTLETABLET301
76420-285-60Clonidine hydrochloride60 in 1 BOTTLETABLET601
76420-285-90Clonidine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-285CLONIDINE HYDROCHLORIDE TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 5 package rows20220919_e8c7aa08-1450-de68-e053-2995a90ad0b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884185cloNIDine HCl 0.2 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884189cloNIDine HCl 0.3 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine HCl 100 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine HCl 200 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884189clonidine HCl 300 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-285-0176420028501100 TABLET in 1 BOTTLE (76420-285-01) 100 tablet2022-09-160000-00-00NoNoCurrent
76420-285-207642002852020 TABLET in 1 BOTTLE (76420-285-20) 20 tablet2022-09-160000-00-00NoNoCurrent
76420-285-307642002853030 TABLET in 1 BOTTLE (76420-285-30) 30 tablet2022-09-160000-00-00NoNoCurrent
76420-285-607642002856060 TABLET in 1 BOTTLE (76420-285-60) 60 tablet2022-09-160000-00-00NoNoCurrent
76420-285-907642002859090 TABLET in 1 BOTTLE (76420-285-90) 90 tablet2022-09-160000-00-00NoNoCurrent