nystatin

Generic: nystatin

Labeler: kesin pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler kesin pharma corporation
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 U/mL

Manufacturer
Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-015
Product ID 81033-015_45b08d8c-c755-d45b-e063-6394a90aa4c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062832
Listing Expiration 2026-12-31
Marketing Start 2020-08-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033015
Hyphenated Format 81033-015

Supplemental Identifiers

RxCUI
312055
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 ANDA062832 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 CASE (81033-015-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)
  • 50 CUP, UNIT-DOSE in 1 CARTON (81033-015-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)
source: ndc

Packages (2)

81033-015-01 100 CUP, UNIT-DOSE in 1 CASE (81033-015-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05) 81033-015-54 50 CUP, UNIT-DOSE in 1 CARTON (81033-015-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)

Ingredients (1)

nystatin (100000 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": "45b08d8c-c755-d45b-e063-6394a90aa4c8", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["43817169-bbe8-58ee-e063-6294a90a1250"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Kesin Pharma Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 CASE (81033-015-01)  / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)", "package_ndc": "81033-015-01", "marketing_start_date": "20251124"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 CARTON (81033-015-54)  / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)", "package_ndc": "81033-015-54", "marketing_start_date": "20251124"}], "brand_name": "NYSTATIN", "product_id": "81033-015_45b08d8c-c755-d45b-e063-6394a90aa4c8", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "81033-015", "generic_name": "NYSTATIN", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/mL"}], "application_number": "ANDA062832", "marketing_category": "ANDA", "marketing_start_date": "20200814", "listing_expiration_date": "20261231"}