nystatin

Generic: nystatin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler proficient rx lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-045
Product ID 82804-045_8566c432-741f-4af7-91d7-1b7668ce5e95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212557
Listing Expiration 2026-12-31
Marketing Start 2019-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804045
Hyphenated Format 82804-045

Supplemental Identifiers

RxCUI
543546
UPC
0382804045150
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 ANDA212557 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 TUBE (82804-045-15)
  • 30 g in 1 TUBE (82804-045-30)
source: ndc

Packages (2)

82804-045-15 15 g in 1 TUBE (82804-045-15) 82804-045-30 30 g in 1 TUBE (82804-045-30)

Ingredients (1)

nystatin (100000 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": "8566c432-741f-4af7-91d7-1b7668ce5e95", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0382804045150"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["8566c432-741f-4af7-91d7-1b7668ce5e95"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (82804-045-15)", "package_ndc": "82804-045-15", "marketing_start_date": "20231208"}, {"sample": false, "description": "30 g in 1 TUBE (82804-045-30)", "package_ndc": "82804-045-30", "marketing_start_date": "20231208"}], "brand_name": "Nystatin", "product_id": "82804-045_8566c432-741f-4af7-91d7-1b7668ce5e95", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "82804-045", "generic_name": "Nystatin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA212557", "marketing_category": "ANDA", "marketing_start_date": "20190724", "listing_expiration_date": "20261231"}