desonide

Generic: desonide

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desonide
Generic Name desonide
Labeler advanced rx of tennessee, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

desonide .5 mg/g

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0371
Product ID 80425-0371_2a999573-102d-813a-e063-6294a90a49b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210198
Listing Expiration 2026-12-31
Marketing Start 2023-12-07

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 804250371
Hyphenated Format 80425-0371

Supplemental Identifiers

RxCUI
349351
UNII
J280872D1O
NUI
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 desonide (source: ndc)
Generic Name desonide (source: ndc)
Application Number ANDA210198 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80425-0371-1) / 60 g in 1 TUBE
source: ndc

Packages (1)

80425-0371-1 1 TUBE in 1 CARTON (80425-0371-1) / 60 g in 1 TUBE

Ingredients (1)

desonide (.5 mg/g)

Linked Drug Pages (1)

Desonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2a999573-102d-813a-e063-6294a90a49b1", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["J280872D1O"], "rxcui": ["349351"], "spl_set_id": ["0beda157-efd4-5245-e063-6394a90a6911"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80425-0371-1)  / 60 g in 1 TUBE", "package_ndc": "80425-0371-1", "marketing_start_date": "20231207"}], "brand_name": "Desonide", "product_id": "80425-0371_2a999573-102d-813a-e063-6294a90a49b1", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0371", "generic_name": "Desonide", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desonide", "active_ingredients": [{"name": "DESONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA210198", "marketing_category": "ANDA", "marketing_start_date": "20231207", "listing_expiration_date": "20261231"}