nystatin

Generic: nystatin

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler nucare pharmaceuticals,inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 66267-953
Product ID 66267-953_1fa7bc90-f395-592a-e063-6394a90acab9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062225
Listing Expiration 2026-12-31
Marketing Start 2006-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66267953
Hyphenated Format 66267-953

Supplemental Identifiers

RxCUI
543546
UPC
0366267953153
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 ANDA062225 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 BOX (66267-953-15)
source: ndc

Packages (1)

66267-953-15 15 g in 1 BOX (66267-953-15)

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": ["TOPICAL"], "spl_id": "1fa7bc90-f395-592a-e063-6394a90acab9", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0366267953153"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["86cfb84c-dcd3-b229-e053-2a91aa0aed5c"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOX (66267-953-15)", "package_ndc": "66267-953-15", "marketing_start_date": "20190418"}], "brand_name": "Nystatin", "product_id": "66267-953_1fa7bc90-f395-592a-e063-6394a90acab9", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "66267-953", "generic_name": "Nystatin", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA062225", "marketing_category": "ANDA", "marketing_start_date": "20060921", "listing_expiration_date": "20261231"}