Erythromycin
ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE
Approved
Approval ID
c7a804bc-dac8-47dc-b7a8-8f2d384652f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2009
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0644
Application NumberANDA062447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 29, 2010
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