FDA.reportPublic FDA data

Catapres

Product NDC
21695-567
11-digit product format
216950567
Labeler code
21695
Product ID
21695-567_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Rebel Distributors Corp
Application
NDA018891
Marketing category
NDA
Marketing start
1985-10-01
Marketing end
0000-00-00
Substance
CLONIDINE
Active strength
0 mg/24h
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-567-042019-09-24C16284748780-1934fe258-4d76-48b1-e053-8cdaa90a720aCatapres-TTS ® -1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-567-04Catapres4 in 1 CARTONPATCH, EXTENDED RELEASE41
21695-567-04Catapres1 in 1 POUCHPATCH, EXTENDED RELEASE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-567-04EA - Each21695-5671bbdc4b6-26b3-4d55-b8fe-b3498673d4d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clonidineACTIVE INGREDIENTMN3L5RMN02CATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
clonidineACTIVE MOIETYMN3L5RMN02CATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPCATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-567CATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110622_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemPSNf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSNf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998673168 HR clonidine 0.00417 MG/HR Transdermal System [Catapres]SBDf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCDf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998673168 HR Catapres 0.00417 MG/HR Transdermal SystemSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998673168 HR Catapres-TTS-1 0.00417 MG/HR Transdermal SystemSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998673Catapres-TTS-1 0.1 MG/Day Weekly Transdermal PatchSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSYf4ac82b0-d0fb-4720-a277-5b2b8013cb3f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-567-04216950567044 in 1 CARTONHistorical