Acebutolol Hydrochloride
Acebutolol Hydrochloride Capsules
Approved
Approval ID
1620c4d3-6a6e-49be-b002-8e4358b0c7d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2021
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
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 Code10135-631
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (10)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Acebutolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-630
Application NumberANDA075047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acebutolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (10)
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT