polycin
Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only
Approved
Approval ID
8108496d-a5d0-45cc-bbbe-93d905bde167
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 sulfates
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-9270
Application NumberANDA065022
Product Classification
M
Marketing Category
C73584
G
Generic Name
bacitracin zinc and polymyxin b sulfates
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 12, 2018
FDA Product Classification
INGREDIENTS (4)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT