nystatin

Generic: nystatin

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler macleods pharmaceuticals limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 1/g

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-469
Product ID 33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213566
Listing Expiration 2026-12-31
Marketing Start 2021-08-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342469
Hyphenated Format 33342-469

Supplemental Identifiers

RxCUI
543546
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 ANDA213566 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 1/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (33342-469-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (33342-469-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

33342-469-15 1 TUBE in 1 CARTON (33342-469-15) / 15 g in 1 TUBE 33342-469-30 1 TUBE in 1 CARTON (33342-469-30) / 30 g in 1 TUBE

Ingredients (1)

nystatin (100000 1/g)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d8ebb61a-a326-4f0d-a346-c3db045c3fb0", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["d8ebb61a-a326-4f0d-a346-c3db045c3fb0"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (33342-469-15)  / 15 g in 1 TUBE", "package_ndc": "33342-469-15", "marketing_start_date": "20210825"}, {"sample": false, "description": "1 TUBE in 1 CARTON (33342-469-30)  / 30 g in 1 TUBE", "package_ndc": "33342-469-30", "marketing_start_date": "20210825"}], "brand_name": "Nystatin", "product_id": "33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "33342-469", "generic_name": "Nystatin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 1/g"}], "application_number": "ANDA213566", "marketing_category": "ANDA", "marketing_start_date": "20210825", "listing_expiration_date": "20261231"}