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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5617
Application NumberANDA050557
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin-Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 20, 2010
FDA Product Classification
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