Erythromycin
Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)
Approved
Approval ID
37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-301
Application NumberANDA064067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 3, 2012
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