BACITRACIN ZINC AND POLYMYXIN B SULFATE
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Approved
Approval ID
8e6c9fb6-c8db-20db-e053-2a95a90a3a86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-017
Application NumberANDA064046
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 24, 2019
FDA Product Classification
INGREDIENTS (4)
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM