nystatin and triamcinolone acetonide

Generic: nystatin and triamcinolone acetonide

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

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide
Generic Name nystatin and triamcinolone acetonide
Labeler lupin pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g, triamcinolone acetonide 1 mg/g

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-545
Product ID 68180-545_8c4a7a07-69ef-4c8c-8db1-a53c46eff737
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208205
Listing Expiration 2026-12-31
Marketing Start 2018-11-29

Pharmacologic Class

Established (EPC)
polyene antifungal [epc] corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180545
Hyphenated Format 68180-545

Supplemental Identifiers

RxCUI
1053753
UPC
0368180545033
UNII
BDF1O1C72E F446C597KA
NUI
N0000175498 M0017172 N0000175576 N0000175450

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 and triamcinolone acetonide (source: ndc)
Generic Name nystatin and triamcinolone acetonide (source: ndc)
Application Number ANDA208205 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68180-545-02) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68180-545-03) / 60 g in 1 TUBE
source: ndc

Packages (2)

68180-545-02 1 TUBE in 1 CARTON (68180-545-02) / 30 g in 1 TUBE 68180-545-03 1 TUBE in 1 CARTON (68180-545-03) / 60 g in 1 TUBE

Ingredients (2)

nystatin (100000 [USP'U]/g) triamcinolone acetonide (1 mg/g)

Linked Drug Pages (1)

Nystatin and Triamcinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8c4a7a07-69ef-4c8c-8db1-a53c46eff737", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "upc": ["0368180545033"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["09140e74-c5ea-4c45-a5b1-e6f7f9ee1a23"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68180-545-02)  / 30 g in 1 TUBE", "package_ndc": "68180-545-02", "marketing_start_date": "20181129"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68180-545-03)  / 60 g in 1 TUBE", "package_ndc": "68180-545-03", "marketing_start_date": "20181129"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "68180-545_8c4a7a07-69ef-4c8c-8db1-a53c46eff737", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68180-545", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin and Triamcinolone Acetonide", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}, {"name": "TRIAMCINOLONE ACETONIDE", "strength": "1 mg/g"}], "application_number": "ANDA208205", "marketing_category": "ANDA", "marketing_start_date": "20181129", "listing_expiration_date": "20261231"}