nystatin and triamcinolone acetonide

Basic Information

Product Name

FDA Product Code

63629-8693

Regulatory Information

NDC Product Code

63629-8693

Application Number

ANDA207380

Marketing Category

C73584

Effective Date

February 23, 2022

Territorial Authority

USA

FDA Title

Nystatin and Triamcinolone Acetonide Ointment, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

103

Active Ingredients

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

TRIAMCINOLONE ACETONIDE

Quantity: 1 mg in 1 g

Code: F446C597KA

Class Code: ACTIB

PETROLATUM

Code: 4T6H12BN9U

Class Code: IACT

NYSTATIN

Quantity: 100000 [USP'U] in 1 g

Code: BDF1O1C72E

Class Code: ACTIB

Active Moieties

NYSTATIN

Code: BDF1O1C72E

TRIAMCINOLONE ACETONIDE

Code: F446C597KA

Basic Information

Regulatory Information

Company Information

Active Ingredients

MINERAL OIL

PETROLATUM

Active Moieties

NYSTATIN

TRIAMCINOLONE ACETONIDE