Erythromycin-Benzoyl Peroxide
Approved
Approval ID
b4cd760f-2ebd-4789-9e53-42141e3def1f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin-Benzoyl Peroxide
PRODUCT DETAILS
NDC Product Code54868-5617
Application NumberANDA050557
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 20, 2010
Generic NameErythromycin-Benzoyl Peroxide
INGREDIENTS (5)
ERYTHROMYCINActive
Quantity: 30 mg in 1 g
Code: 63937KV33D
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT