nystatin

Generic: nystatin

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 68308-152
Product ID 68308-152_b52f2a01-5158-458f-beed-60314e69f27d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065203
Marketing Start 2004-07-15
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
polyene antifungal [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308152
Hyphenated Format 68308-152

Supplemental Identifiers

RxCUI
646456
UPC
0368308152150
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

Packaging Origin

Original Packager
true

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)
  • 60 g in 1 BOTTLE, PLASTIC (68308-152-60)
source: ndc

Packages (2)

68308-152-15 15 g in 1 BOTTLE, PLASTIC (68308-152-15) 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": "b52f2a01-5158-458f-beed-60314e69f27d", "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_end_date": "20260331", "marketing_start_date": "20040715"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (68308-152-60)", "package_ndc": "68308-152-60", "marketing_end_date": "20260331", "marketing_start_date": "20040715"}], "brand_name": "Nystatin", "product_id": "68308-152_b52f2a01-5158-458f-beed-60314e69f27d", "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_end_date": "20260331", "marketing_start_date": "20040715"}