FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
0228-4241
11-digit product format
002284241
Labeler code
0228
Product ID
0228-4241_5082cfd3-e748-4c4b-81ba-0957f02244a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA203320
Marketing category
ANDA
Marketing start
2015-06-17
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
Rxcui1013930

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
0228-4241-06Clonidine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE6027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-4241CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]26Current NDC, Legacy NDC, 1 package rows20240315_0100c70d-7fde-46a1-8374-940550a27e43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN0100c70d-7fde-46a1-8374-940550a27e4327
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD0100c70d-7fde-46a1-8374-940550a27e4327
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY0100c70d-7fde-46a1-8374-940550a27e4327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-4241-060022842410660 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-4241-06) 2015-06-170000-00-00NoNoCurrent