nystatin and triamcinolone acetonide

Generic: nystatin and triamcinolone acetonide

Labeler: preferred 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 preferred pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8662
Product ID 68788-8662_ce8d805f-76f5-4d8c-9fc1-cc376715d528
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214181
Listing Expiration 2027-12-31
Marketing Start 2024-05-13

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 687888662
Hyphenated Format 68788-8662

Supplemental Identifiers

RxCUI
1053753
UNII
BDF1O1C72E F446C597KA
NUI
N0000175498 M0017172 N0000175576 N0000175450

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 ANDA214181 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-8662-3) / 30 g in 1 TUBE
source: ndc

Packages (1)

68788-8662-3 1 TUBE in 1 CARTON (68788-8662-3) / 30 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": "ce8d805f-76f5-4d8c-9fc1-cc376715d528", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["c529567b-7061-4389-8c7a-20ef2b22c591"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-8662-3)  / 30 g in 1 TUBE", "package_ndc": "68788-8662-3", "marketing_start_date": "20240513"}], "brand_name": "Nystatin and triamcinolone acetonide", "product_id": "68788-8662_ce8d805f-76f5-4d8c-9fc1-cc376715d528", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68788-8662", "generic_name": "Nystatin and triamcinolone acetonide", "labeler_name": "Preferred 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": "ANDA214181", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20271231"}