FDA.reportPublic FDA data

Clonidine transdermal system

Product NDC
0591-3509
11-digit product format
005913509
Labeler code
0591
Product ID
0591-3509_996f475b-4f8b-4487-b5c1-6e5c4f284045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090873
Marketing category
ANDA
Marketing start
2014-05-06
Substance
CLONIDINE
Active strength
.2 mg/d
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 transdermal system
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE.2 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
0591-3509-04Clonidine transdermal system4 in 1 CARTONPATCH413
0591-3509-54Clonidine transdermal system1 in 1 POUCHPATCH113
0591-3509-54Clonidine transdermal system7 d in 1 PATCHPATCH713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3509-04EA - Each0591-3509a8beb8ec-53af-4059-941c-cd8e6ba6fe0212014-06-03
0591-3509-54EA - Each0591-350928e48552-aa53-4076-8524-89d9a787de0712015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINEACTIVE INGREDIENTMN3L5RMN02CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE) PATCH [ACTAVIS PHARMA, INC.]4
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE) PATCH [ACTAVIS PHARMA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3509CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE) PATCH [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 3 package rows20231216_99a59495-2a48-4276-bbe3-cdd55a45aba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSN99a59495-2a48-4276-bbe3-cdd55a45aba413
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSN99a59495-2a48-4276-bbe3-cdd55a45aba413
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSN99a59495-2a48-4276-bbe3-cdd55a45aba413
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCD99a59495-2a48-4276-bbe3-cdd55a45aba413
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCD99a59495-2a48-4276-bbe3-cdd55a45aba413
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCD99a59495-2a48-4276-bbe3-cdd55a45aba413
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSY99a59495-2a48-4276-bbe3-cdd55a45aba413
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSY99a59495-2a48-4276-bbe3-cdd55a45aba413
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSY99a59495-2a48-4276-bbe3-cdd55a45aba413
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSY99a59495-2a48-4276-bbe3-cdd55a45aba413
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSY99a59495-2a48-4276-bbe3-cdd55a45aba413
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSY99a59495-2a48-4276-bbe3-cdd55a45aba413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3509-04005913509044 POUCH in 1 CARTON (0591-3509-04) / 1 PATCH in 1 POUCH (0591-3509-54) / 7 d in 1 PATCH4 pouch2014-05-060000-00-00NoNoCurrent
0591-3509-54005913509541 in 1 POUCHHistorical