Erythromycin and Benzoyl Peroxide
Erythromycin and Benzoyl Peroxide Topical Gel USP
Approved
Approval ID
d449d7e2-5c25-406d-87ab-30809d292476
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin and Benzoyl Peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-328
Application NumberANDA065385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin and Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (7)
BENZOYL PEROXIDEActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
CARBOMER 940Inactive
Code: 4Q93RCW27E
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ERYTHROMYCINActive
Quantity: 30 mg in 1 g
Code: 63937KV33D
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT