nystatin

Generic: nystatin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler preferred pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8631
Product ID 68788-8631_efb3a87c-639a-4cd2-905a-73e79bd7778b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212557
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888631
Hyphenated Format 68788-8631

Supplemental Identifiers

RxCUI
543546
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

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 ANDA212557 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 TUBE (68788-8631-1)
  • 30 g in 1 TUBE (68788-8631-3)
source: ndc

Packages (2)

68788-8631-1 15 g in 1 TUBE (68788-8631-1) 68788-8631-3 30 g in 1 TUBE (68788-8631-3)

Ingredients (1)

nystatin (100000 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": "efb3a87c-639a-4cd2-905a-73e79bd7778b", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["d92f67a7-dcae-41c0-9a35-dbafa2361170"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (68788-8631-1)", "package_ndc": "68788-8631-1", "marketing_start_date": "20240415"}, {"sample": false, "description": "30 g in 1 TUBE (68788-8631-3)", "package_ndc": "68788-8631-3", "marketing_start_date": "20240415"}], "brand_name": "Nystatin", "product_id": "68788-8631_efb3a87c-639a-4cd2-905a-73e79bd7778b", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68788-8631", "generic_name": "Nystatin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA212557", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}