MedPath

Nystop

Nystatin Topical Powder, USP For topical use only.Not for ophthalmic use.

Approved
Approval ID

69ebb4dd-f45d-448d-97cd-3f8935493975

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Nystatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63629-8698
Application NumberANDA064118
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (2)

NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/30/2011

Nystatin 100000 unit/gram Powder, #60

Label

DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/2/2024

DESCRIPTION

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1.

Structural formula:

Structural Formula

Nystatin Topical Powder USP is for dermatologic use.

Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 8/26/2025

HOW SUPPLIED

Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 60 g plastic squeeze bottles.

(NDC 63629-8698-1)

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F).

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Nystop - FDA Drug Approval Details