SECTRAL
Approved
Approval ID
7eee95bf-0452-4d6e-9712-33403768695a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2012
Manufacturers
FDA
Promius Pharma, LLC
DUNS: 020408265
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 Code67857-700
Application NumberNDA018917
Product Classification
M
Marketing Category
C73594
G
Generic Name
acebutolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2012
FDA Product Classification
INGREDIENTS (10)
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C Red No. 22Inactive
Code: 1678RKX8RT
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
acebutolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67857-701
Application NumberNDA018917
Product Classification
M
Marketing Category
C73594
G
Generic Name
acebutolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2012
FDA Product Classification
INGREDIENTS (10)
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ACEBUTOLOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: B025Y34C54
Classification: ACTIM
D&C Red No. 22Inactive
Code: 1678RKX8RT
Classification: IACT