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
NDC Product Code67857-700
Application NumberNDA018917
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 12, 2012
Generic Nameacebutolol hydrochloride
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
NDC Product Code67857-701
Application NumberNDA018917
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 12, 2012
Generic Nameacebutolol hydrochloride
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