nystatin

Generic: nystatin

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

nystatin 500000 [USP'U]/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-051
Product ID 23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062474
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155051
Hyphenated Format 23155-051

Supplemental Identifiers

RxCUI
312059
UPC
0323155051018
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 ANDA062474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (23155-051-01)
source: ndc

Packages (1)

23155-051-01 100 TABLET, COATED in 1 BOTTLE (23155-051-01)

Ingredients (1)

nystatin (500000 [USP'U]/1)

Linked Drug Pages (1)

nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d5c4ffad-b502-4226-9ff2-8603aac88dba", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0323155051018"], "unii": ["BDF1O1C72E"], "rxcui": ["312059"], "spl_set_id": ["e87b8480-987d-4f82-87bf-cf831d6984a1"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (23155-051-01)", "package_ndc": "23155-051-01", "marketing_start_date": "20111031"}], "brand_name": "nystatin", "product_id": "23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dba", "dosage_form": "TABLET, COATED", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "23155-051", "generic_name": "nystatin", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA062474", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}