Clonidine
Clonidine Transdermal System(clonidine)
Approved
Approval ID
996d9246-e5d2-48a2-be8d-9ef5c8f64b1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clonidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6214
Application NumberANDA076157
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateOctober 3, 2011
FDA Product Classification
INGREDIENTS (2)
ClonidineActive
Quantity: 0.2 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
Clonidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6310
Application NumberANDA076157
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateOctober 3, 2011
FDA Product Classification
INGREDIENTS (2)
ClonidineActive
Quantity: 0.1 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
Clonidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6260
Application NumberANDA076157
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonidine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateOctober 3, 2011
FDA Product Classification
INGREDIENTS (2)
ClonidineActive
Quantity: 0.3 mg in 1 d
Code: MN3L5RMN02
Classification: ACTIB
Isopropyl PalmitateInactive
Code: 8CRQ2TH63M
Classification: IACT