nystatin

Generic: nystatin

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler leading pharma, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-504
Product ID 69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214346
Listing Expiration 2026-12-31
Marketing Start 2022-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315504
Hyphenated Format 69315-504

Supplemental Identifiers

RxCUI
312055
UPC
0369315504475
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 ANDA214346 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69315-504-47)
  • 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

69315-504-47 473 mL in 1 BOTTLE (69315-504-47) 69315-504-60 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE

Ingredients (1)

nystatin (100000 [USP'U]/mL)

Linked Drug Pages (1)

NYSTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb4efca9-e5e8-4509-9437-6ad7c593a9ef", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0369315504475"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["954205d8-47ba-4c89-95cd-f0066a514cf9"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69315-504-47)", "package_ndc": "69315-504-47", "marketing_start_date": "20221205"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (69315-504-60)  / 60 mL in 1 BOTTLE", "package_ndc": "69315-504-60", "marketing_start_date": "20221205"}], "brand_name": "NYSTATIN", "product_id": "69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "69315-504", "generic_name": "NYSTATIN", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA214346", "marketing_category": "ANDA", "marketing_start_date": "20221205", "listing_expiration_date": "20261231"}