nystatin

Generic: nystatin ointment

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

Drug Facts

Product Profile

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

nystatin 100000 [USP'U]/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-437
Product ID 71205-437_711950c4-1889-4acd-ab76-9a16176ce1e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209114
Listing Expiration 2026-12-31
Marketing Start 2017-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205437
Hyphenated Format 71205-437

Supplemental Identifiers

RxCUI
884308
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 ointment (source: ndc)
Application Number ANDA209114 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (71205-437-15) / 15 g in 1 TUBE
source: ndc

Packages (1)

71205-437-15 1 TUBE in 1 CARTON (71205-437-15) / 15 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": "711950c4-1889-4acd-ab76-9a16176ce1e4", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["884308"], "spl_set_id": ["711950c4-1889-4acd-ab76-9a16176ce1e4"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (71205-437-15)  / 15 g in 1 TUBE", "package_ndc": "71205-437-15", "marketing_start_date": "20200319"}], "brand_name": "Nystatin", "product_id": "71205-437_711950c4-1889-4acd-ab76-9a16176ce1e4", "dosage_form": "OINTMENT", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "71205-437", "generic_name": "Nystatin Ointment", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA209114", "marketing_category": "ANDA", "marketing_start_date": "20171006", "listing_expiration_date": "20261231"}