Nystatin Topical Powder, Usp

SPL v5

SPL

SPL Set ID 5d593aa9-f2e4-4adf-9f02-37832ffcb5b4

Route

TOPICAL

Published

Effective Date 2024-07-29

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Nystatin (100000 [USP'U])

Inactive Ingredients

Talc

Identifiers & Packaging

Marketing Status

ANDA Active Since 2021-10-06

Description

NDC 70771-1585-1 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS

Medication Information

Description

NDC 70771-1585-1 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS

Package Label.principal Display Panel

NDC 70771-1585-1

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

15 GRAMS

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1585-1

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

15 GRAMS

Advanced Ingredient Data

[{"name": "NYSTATIN", "unii": "BDF1O1C72E", "classCode": "ACTIB", "strengthNumerator": "100000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1585-1 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:01.505925 · Updated: 2026-03-14T22:18:26.158923