nystatin

Generic: nystatin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler aurobindo pharma limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-907
Product ID 59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219527
Listing Expiration 2026-12-31
Marketing Start 2025-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651907
Hyphenated Format 59651-907

Supplemental Identifiers

RxCUI
543546
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 ANDA219527 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

59651-907-14 1 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE 59651-907-30 1 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

NYSTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1a24e1d4-b691-4849-822a-9a9a4aed4b27", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["7d8a30ab-465e-4804-a06b-afd689e16683"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (59651-907-14)  / 15 g in 1 TUBE", "package_ndc": "59651-907-14", "marketing_start_date": "20250321"}, {"sample": false, "description": "1 TUBE in 1 CARTON (59651-907-30)  / 30 g in 1 TUBE", "package_ndc": "59651-907-30", "marketing_start_date": "20250321"}], "brand_name": "NYSTATIN", "product_id": "59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "59651-907", "generic_name": "NYSTATIN", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA219527", "marketing_category": "ANDA", "marketing_start_date": "20250321", "listing_expiration_date": "20261231"}