nystatin

Generic: nystatin

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler direct rx
Dosage Form CREAM
Routes
ORAL TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-278
Product ID 72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064022
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189278
Hyphenated Format 72189-278

Supplemental Identifiers

RxCUI
543546
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 ANDA064022 (source: ndc)
Routes
ORAL TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 BOX (72189-278-15)
source: ndc

Packages (1)

72189-278-15 15 g in 1 BOX (72189-278-15)

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": ["ORAL", "TOPICAL"], "spl_id": "2c290c08-d35f-21b4-e063-6394a90a73b9", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["cd387929-5b72-e3c0-e053-2a95a90adb22"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOX (72189-278-15)", "package_ndc": "72189-278-15", "marketing_start_date": "20210930"}], "brand_name": "NYSTATIN", "product_id": "72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "72189-278", "generic_name": "NYSTATIN", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA064022", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}