nystatin and triamcinolone acetonide (13668-610)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler torrent pharmaceuticals limited

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-610

Product ID 13668-610_bc17b856-f6f4-4f64-831c-1819811c0ecb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213142

Listing Expiration 2026-12-31

Marketing Start 2020-07-14

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 13668610

Hyphenated Format 13668-610

Supplemental Identifiers

RxCUI

1053753

UPC

0313668610017

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 ANDA213142 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

1 TUBE in 1 CARTON (13668-610-01) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (13668-610-02) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (13668-610-05) / 60 g in 1 TUBE

source: ndc

Packages (3)

13668-610-01 1 TUBE in 1 CARTON (13668-610-01) / 15 g in 1 TUBE 13668-610-02 1 TUBE in 1 CARTON (13668-610-02) / 30 g in 1 TUBE 13668-610-05 1 TUBE in 1 CARTON (13668-610-05) / 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": "bc17b856-f6f4-4f64-831c-1819811c0ecb", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "upc": ["0313668610017"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["b20217ad-8c25-471a-9f16-9e681b90db05"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (13668-610-01)  / 15 g in 1 TUBE", "package_ndc": "13668-610-01", "marketing_start_date": "20200714"}, {"sample": false, "description": "1 TUBE in 1 CARTON (13668-610-02)  / 30 g in 1 TUBE", "package_ndc": "13668-610-02", "marketing_start_date": "20200714"}, {"sample": false, "description": "1 TUBE in 1 CARTON (13668-610-05)  / 60 g in 1 TUBE", "package_ndc": "13668-610-05", "marketing_start_date": "20200714"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "13668-610_bc17b856-f6f4-4f64-831c-1819811c0ecb", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "13668-610", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Torrent Pharmaceuticals Limited", "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": "ANDA213142", "marketing_category": "ANDA", "marketing_start_date": "20200714", "listing_expiration_date": "20261231"}