nystatin and triamcinolone acetonide (68462-314)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler glenmark pharmaceuticals inc., usa

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-314

Product ID 68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208136

Listing Expiration 2026-12-31

Marketing Start 2016-10-24

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 68462314

Hyphenated Format 68462-314

Supplemental Identifiers

RxCUI

1053753

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 ANDA208136 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

100000 [USP'U]/g
1 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (68462-314-17) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (68462-314-35) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (68462-314-65) / 60 g in 1 TUBE

source: ndc

Packages (3)

68462-314-17 1 TUBE in 1 CARTON (68462-314-17) / 15 g in 1 TUBE 68462-314-35 1 TUBE in 1 CARTON (68462-314-35) / 30 g in 1 TUBE 68462-314-65 1 TUBE in 1 CARTON (68462-314-65) / 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": "39b52cdc-3387-4aac-9a01-e4c6ae68f282", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["44a37f35-e533-4b09-bbcf-97ffaff1920b"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-314-17)  / 15 g in 1 TUBE", "package_ndc": "68462-314-17", "marketing_start_date": "20161025"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-314-35)  / 30 g in 1 TUBE", "package_ndc": "68462-314-35", "marketing_start_date": "20161025"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-314-65)  / 60 g in 1 TUBE", "package_ndc": "68462-314-65", "marketing_start_date": "20161025"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68462-314", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "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": "ANDA208136", "marketing_category": "ANDA", "marketing_start_date": "20161024", "listing_expiration_date": "20261231"}