nystatin and triamcinolone acetonide (51672-1272)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler sun pharmaceutical industries, inc.

Dosage Form OINTMENT

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1272

Product ID 51672-1272_395e7f1c-ecc8-31cf-e063-6294a90aef62

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA063305

Listing Expiration 2026-12-31

Marketing Start 1993-03-29

Pharmacologic Class

Established (EPC)

corticosteroid [epc] polyene antifungal [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 516721272

Hyphenated Format 51672-1272

Supplemental Identifiers

RxCUI

1053697 1053753

UNII

F446C597KA BDF1O1C72E

NUI

N0000175576 N0000175450 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 and triamcinolone acetonide (source: ndc)

Generic Name nystatin and triamcinolone acetonide (source: ndc)

Application Number ANDA063305 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

1 TUBE in 1 CARTON (51672-1272-1) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (51672-1272-2) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (51672-1272-3) / 60 g in 1 TUBE

source: ndc

Packages (3)

51672-1272-1 1 TUBE in 1 CARTON (51672-1272-1) / 15 g in 1 TUBE 51672-1272-2 1 TUBE in 1 CARTON (51672-1272-2) / 30 g in 1 TUBE 51672-1272-3 1 TUBE in 1 CARTON (51672-1272-3) / 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": "395e7f1c-ecc8-31cf-e063-6294a90aef62", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175498", "M0017172"], "unii": ["F446C597KA", "BDF1O1C72E"], "rxcui": ["1053697", "1053753"], "spl_set_id": ["2fd97fc5-cae5-43dd-a3c7-c9a03876153e"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Polyene Antifungal [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1272-1)  / 15 g in 1 TUBE", "package_ndc": "51672-1272-1", "marketing_start_date": "19930329"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1272-2)  / 30 g in 1 TUBE", "package_ndc": "51672-1272-2", "marketing_start_date": "19930329"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1272-3)  / 60 g in 1 TUBE", "package_ndc": "51672-1272-3", "marketing_start_date": "19930329"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "51672-1272_395e7f1c-ecc8-31cf-e063-6294a90aef62", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "51672-1272", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Sun Pharmaceutical Industries, 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": "ANDA063305", "marketing_category": "ANDA", "marketing_start_date": "19930329", "listing_expiration_date": "20261231"}