Acebutolol Hydrochloride
ACEBUTOLOL HYDROCHLORIDE CAPSULES, USPRx Only
Approved
Approval ID
fe2cd5c0-ee16-4bcb-ad92-3755881dbe79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code53746-669
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
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
Acebutolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-670
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
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