Neo Polycin HC

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 967694121

Effective Date

December 10, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Neomycin(3.5 mg in 1 g)

Polymyxin B(10000 [USP'U] in 1 g)

Bacitracin(400 [USP'U] in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0574-4144

Application Number

ANDA062166

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

November 9, 2018

Ingredients

Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 g

Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g

Code: 89Y4M234ESClass: ACTIMQuantity: 400 [USP'U] in 1 g

PETROLATUMInactive

Code: 4T6H12BN9UClass: IACT

Code: 3X7931PO74Class: ACTIBQuantity: 10 mg in 1 g

MINERAL OILInactive

Code: T5L8T28FGPClass: IACT