topicort

Generic: desoximetasone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name topicort
Generic Name desoximetasone
Labeler sun pharmaceutical industries, inc.
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

desoximetasone 2.5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-5281
Product ID 51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204141
Listing Expiration 2026-12-31
Marketing Start 2013-04-11

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516725281
Hyphenated Format 51672-5281

Supplemental Identifiers

RxCUI
1376338 1376340
UNII
4E07GXB7AU
NUI
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 topicort (source: ndc)
Generic Name desoximetasone (source: ndc)
Application Number NDA204141 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-5281-0) / 6 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-5281-3) / 30 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-5281-4) / 50 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (51672-5281-6) / 50 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-5281-7) / 100 mL in 1 BOTTLE
source: ndc

Packages (5)

51672-5281-0 1 BOTTLE in 1 CARTON (51672-5281-0) / 6 mL in 1 BOTTLE 51672-5281-3 1 BOTTLE in 1 CARTON (51672-5281-3) / 30 mL in 1 BOTTLE 51672-5281-4 1 BOTTLE in 1 CARTON (51672-5281-4) / 50 mL in 1 BOTTLE 51672-5281-6 2 BOTTLE in 1 CARTON (51672-5281-6) / 50 mL in 1 BOTTLE 51672-5281-7 1 BOTTLE in 1 CARTON (51672-5281-7) / 100 mL in 1 BOTTLE

Ingredients (1)

desoximetasone (2.5 mg/mL)

Linked Drug Pages (1)

Topicort ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "38f9cadb-290c-0c68-e063-6394a90a38d9", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["4E07GXB7AU"], "rxcui": ["1376338", "1376340"], "spl_set_id": ["e417856a-b760-4626-bc34-8e4bc62c026c"], "pharm_class_epc": ["Corticosteroid [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 BOTTLE in 1 CARTON (51672-5281-0)  / 6 mL in 1 BOTTLE", "package_ndc": "51672-5281-0", "marketing_start_date": "20130411"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-5281-3)  / 30 mL in 1 BOTTLE", "package_ndc": "51672-5281-3", "marketing_start_date": "20130411"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-5281-4)  / 50 mL in 1 BOTTLE", "package_ndc": "51672-5281-4", "marketing_start_date": "20130411"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (51672-5281-6)  / 50 mL in 1 BOTTLE", "package_ndc": "51672-5281-6", "marketing_start_date": "20130411"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-5281-7)  / 100 mL in 1 BOTTLE", "package_ndc": "51672-5281-7", "marketing_start_date": "20130411"}], "brand_name": "Topicort", "product_id": "51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-5281", "generic_name": "Desoximetasone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topicort", "active_ingredients": [{"name": "DESOXIMETASONE", "strength": "2.5 mg/mL"}], "application_number": "NDA204141", "marketing_category": "NDA", "marketing_start_date": "20130411", "listing_expiration_date": "20261231"}