mycostatin

Generic: nystatin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycostatin
Generic Name nystatin
Labeler direct_rx
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-408
Product ID 72189-408_2c4cf342-0925-a4ec-e063-6294a90a7a28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062225
Listing Expiration 2026-12-31
Marketing Start 2023-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189408
Hyphenated Format 72189-408

Supplemental Identifiers

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 mycostatin (source: ndc)
Generic Name nystatin (source: ndc)
Application Number ANDA062225 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 TUBE (72189-408-15)
source: ndc

Packages (1)

72189-408-15 15 g in 1 TUBE (72189-408-15)

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Mycostatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2c4cf342-0925-a4ec-e063-6294a90a7a28", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "spl_set_id": ["f1857ac0-806c-4a7e-e053-2995a90abbc0"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (72189-408-15)", "package_ndc": "72189-408-15", "marketing_start_date": "20230105"}], "brand_name": "Mycostatin", "product_id": "72189-408_2c4cf342-0925-a4ec-e063-6294a90a7a28", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "72189-408", "generic_name": "Nystatin", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycostatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA062225", "marketing_category": "ANDA", "marketing_start_date": "20230105", "listing_expiration_date": "20261231"}