erythromycin
ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY
Approved
Approval ID
ee7d5cdd-86c5-4dd3-89fc-3c4ad108799b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
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 Code70518-0392
Application NumberANDA062447
Product Classification
M
Marketing Category
C73584
G
Generic Name
erythromycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (3)
ERYTHROMYCINActive
Quantity: 5 mg in 1 g
Code: 63937KV33D
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT