Nystatin

Generic: Nystatin

Labeler: Mayne Pharma Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Nystatin
Generic Name Nystatin
Labeler Mayne Pharma Inc.
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

NYSTATIN 100000 [USP'U]/g

Identifiers & Regulatory

Product NDC 68308-152
Product ID 68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065203
Listing Expiration 2026-12-31
Marketing Start 2004-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308152
Hyphenated Format 68308-152

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name Nystatin (source: ndc)
Generic Name Nystatin (source: ndc)
Application Number ANDA065203 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 BOTTLE, PLASTIC (68308-152-15)
  • 30 g in 1 BOTTLE, PLASTIC (68308-152-30)
  • 60 g in 1 BOTTLE, PLASTIC (68308-152-60)
source: ndc

Packages (3)

68308-152-15 15 g in 1 BOTTLE, PLASTIC (68308-152-15) 68308-152-30 30 g in 1 BOTTLE, PLASTIC (68308-152-30) 68308-152-60 60 g in 1 BOTTLE, PLASTIC (68308-152-60)

Ingredients (1)

NYSTATIN (100000 [USP'U]/g)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "9bd397a3-24b8-4420-9adb-9917a8d6b233", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0368308152150"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["656fc23b-65af-465e-9bcb-67fbbfa9b84e"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOTTLE, PLASTIC (68308-152-15)", "package_ndc": "68308-152-15", "marketing_start_date": "20040715"}, {"sample": false, "description": "30 g in 1 BOTTLE, PLASTIC (68308-152-30)", "package_ndc": "68308-152-30", "marketing_start_date": "20040715"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (68308-152-60)", "package_ndc": "68308-152-60", "marketing_start_date": "20040715"}], "brand_name": "Nystatin", "product_id": "68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68308-152", "generic_name": "Nystatin", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA065203", "marketing_category": "ANDA", "marketing_start_date": "20040715", "listing_expiration_date": "20261231"}