Erythromycin
Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)
Approved
Approval ID
d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-173
Application NumberANDA064067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 9, 2008
FDA Product Classification
INGREDIENTS (3)
ERYTHROMYCINActive
Quantity: 5 mg in 1 g
Code: 63937KV33D
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT