Erythromycin
apexa™ErythromycinOphthalmic Ointment USP, 0.5%STERILERx Only
Approved
Approval ID
407ff426-4cca-4b65-b2d3-eb2f078bfa39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2022
Manufacturers
FDA
MWI
DUNS: 019926120
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13985-605
Application NumberANDA064030
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 23, 2015
FDA Product Classification
INGREDIENTS (3)
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
ErythromycinActive
Quantity: 5 mg in 1 g
Code: 63937KV33D
Classification: ACTIB