FDA.reportPublic FDA data

Catapres-TTS-2

Product NDC
82089-102
11-digit product format
820890102
Labeler code
82089
Product ID
82089-102_e826dfa2-e206-4274-8354-c47f17a04f5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine transdermal system
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Technomed Inc.
Application
NDA018891
Marketing category
NDA
Marketing start
2022-03-01
Marketing end
2026-10-30
Substance
CLONIDINE
Active strength
.2 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
Catapres-TTS-2

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE.2 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMN3L5RMN02
Rxcui998671, 998673, 998675, 998677, 998679, 998681

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
82089-102-34Catapres-TTS-24 in 1 CARTONPATCH44
82089-102-34Catapres-TTS-21 in 1 POUCHPATCH14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82089-102-34EA - Each82089-102249d50a6-887f-4570-8569-b096ce51b68f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82089-102CATAPRES-TTS-1 (CLONIDINE TRANSDERMAL SYSTEM) PATCH CATAPRES-TTS-2 (CLONIDINE TRANSDERMAL SYSTEM) PATCH CATAPRES-TTS-3 (CLONIDINE TRANSDERMAL SYSTEM) PATCH [TECHNOMED INC.]4Current NDC, Legacy NDC, 2 package rows20241018_d4a55825-7041-42f4-b3b2-dd7a25dbe793.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR clonidine 0.00417 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR clonidine 0.00833 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR clonidine 0.0125 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR Catapres 0.00417 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR Catapres 0.00833 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR Catapres 0.0125 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR Catapres-TTS-1 0.00417 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR Catapres-TTS-2 0.00833 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR Catapres-TTS-3 0.0125 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673Catapres-TTS-1 0.1 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day 7 Day Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day 7 Day Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82089-102-34820890102344 POUCH in 1 CARTON (82089-102-34) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH4 pouch2022-03-012026-10-30NoNoCurrent