nystatin

Generic: nystatin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

nystatin 500000 [USP'U]/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8350
Product ID 63629-8350_3ac0334d-5698-4b3a-8ac8-7594526ec50c
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 636298350
Hyphenated Format 63629-8350

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 28 TABLET, COATED in 1 BOTTLE (63629-8350-1)
  • 56 TABLET, COATED in 1 BOTTLE (63629-8350-2)
  • 30 TABLET, COATED in 1 BOTTLE (63629-8350-3)
  • 120 TABLET, COATED in 1 BOTTLE (63629-8350-4)
source: ndc

Packages (4)

63629-8350-1 28 TABLET, COATED in 1 BOTTLE (63629-8350-1) 63629-8350-2 56 TABLET, COATED in 1 BOTTLE (63629-8350-2) 63629-8350-3 30 TABLET, COATED in 1 BOTTLE (63629-8350-3) 63629-8350-4 120 TABLET, COATED in 1 BOTTLE (63629-8350-4)

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": "3ac0334d-5698-4b3a-8ac8-7594526ec50c", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312059"], "spl_set_id": ["a5711dbe-f71c-435c-91f2-38c357532d18"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, COATED in 1 BOTTLE (63629-8350-1)", "package_ndc": "63629-8350-1", "marketing_start_date": "20220429"}, {"sample": false, "description": "56 TABLET, COATED in 1 BOTTLE (63629-8350-2)", "package_ndc": "63629-8350-2", "marketing_start_date": "20200902"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (63629-8350-3)", "package_ndc": "63629-8350-3", "marketing_start_date": "20200902"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (63629-8350-4)", "package_ndc": "63629-8350-4", "marketing_start_date": "20240607"}], "brand_name": "nystatin", "product_id": "63629-8350_3ac0334d-5698-4b3a-8ac8-7594526ec50c", "dosage_form": "TABLET, COATED", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "63629-8350", "generic_name": "nystatin", "labeler_name": "Bryant Ranch Prepack", "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"}