nystatin

Generic: nystatin

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nystatin 500000 [USP'U]/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-741
Product ID 62135-741_462a7357-7985-7f48-e063-6294a90ac5c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062474
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135741
Hyphenated Format 62135-741

Supplemental Identifiers

RxCUI
312059
UPC
0362135741907
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 ANDA062474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-741-90)
source: ndc

Packages (1)

62135-741-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-741-90)

Ingredients (1)

nystatin (500000 [USP'U]/1)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462a7357-7985-7f48-e063-6294a90ac5c8", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0362135741907"], "unii": ["BDF1O1C72E"], "rxcui": ["312059"], "spl_set_id": ["30175930-f5fa-403d-a3ac-3bdbbe723641"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-741-90)", "package_ndc": "62135-741-90", "marketing_start_date": "20230808"}], "brand_name": "Nystatin", "product_id": "62135-741_462a7357-7985-7f48-e063-6294a90ac5c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "62135-741", "generic_name": "Nystatin", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA062474", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}