FDA.reportPublic FDA data

Clonidine Transdermal System USP, 0.3 mg/day

Product NDC
52817-612
11-digit product format
528170612
Labeler code
52817
Product ID
52817-612_304ded76-8279-4755-84e9-ad226ba034e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine transdermal system
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
TruPharma, LLC
Application
NDA018891
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-06-30
Marketing end
2026-10-30
Substance
CLONIDINE
Active strength
.3 mg/d
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Transdermal System USP, 0.3 mg/day

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE.3 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMN3L5RMN02
Rxcui998671, 998675, 998679

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
52817-612-04Clonidine Transdermal System USP, 0.3 mg/day4 in 1 CARTONPATCH43
52817-612-04Clonidine Transdermal System USP, 0.3 mg/day1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-612CLONIDINE TRANSDERMAL SYSTEM USP, 0.1 MG/DAY (CLONIDINE TRANSDERMAL SYSTEM) PATCH CLONIDINE TRANSDERMAL SYSTEM USP, 0.2 MG/DAY (CLONIDINE TRANSDERMAL SYSTEM) PATCH CLONIDINE TRANSDERMAL SYSTEM USP, 0.3 MG/DAY (CLONIDINE TRANSDERMAL SYSTEM) PATCH [TRUPHARMA, LLC]3Current NDC, 2 package rows20250424_05d520bf-3ab7-4337-9f38-4418e5e7e1e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSN05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSN05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSN05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCD05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCD05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCD05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSY05d520bf-3ab7-4337-9f38-4418e5e7e1e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-612-04528170612044 POUCH in 1 CARTON (52817-612-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH4 pouch2023-06-302026-10-30NoNoHistorical