Bacitracin
BACITRACIN OPHTHALMICOINTMENT USPSTERILE
Approved
Approval ID
2023b121-67d3-499a-ae7f-526cc9bafbc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 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.
Bacitracin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0649
Application NumberANDA061212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 30, 2010
FDA Product Classification
INGREDIENTS (3)
BACITRACINActive
Quantity: 500 [iU] in 1 g
Code: 58H6RWO52I
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT