Acebutolol Hydrochloride
ACEBUTOLOL HYDROCHLORIDE CAPSULES
Approved
Approval ID
201b752c-64b4-4687-acc1-3a92bfda864e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acebutolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4216
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (2)
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Acebutolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5520
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (2)
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT