desonide

Generic: desonide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desonide
Generic Name desonide
Labeler alembic pharmaceuticals limited
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

desonide .5 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-485
Product ID 46708-485_98a69c58-33de-41e1-a26f-7a4152605f05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212473
Listing Expiration 2026-12-31
Marketing Start 2025-03-07

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 46708485
Hyphenated Format 46708-485

Supplemental Identifiers

RxCUI
204135
UPC
0346708485153
UNII
J280872D1O
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 desonide (source: ndc)
Generic Name desonide (source: ndc)
Application Number ANDA212473 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (46708-485-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-485-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

46708-485-15 1 TUBE in 1 CARTON (46708-485-15) / 15 g in 1 TUBE 46708-485-60 1 TUBE in 1 CARTON (46708-485-60) / 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": "98a69c58-33de-41e1-a26f-7a4152605f05", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0346708485153"], "unii": ["J280872D1O"], "rxcui": ["204135"], "spl_set_id": ["591762b3-f223-49a1-8e65-63e9086110df"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-485-15)  / 15 g in 1 TUBE", "package_ndc": "46708-485-15", "marketing_start_date": "20250307"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-485-60)  / 60 g in 1 TUBE", "package_ndc": "46708-485-60", "marketing_start_date": "20250307"}], "brand_name": "Desonide", "product_id": "46708-485_98a69c58-33de-41e1-a26f-7a4152605f05", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-485", "generic_name": "Desonide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desonide", "active_ingredients": [{"name": "DESONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA212473", "marketing_category": "ANDA", "marketing_start_date": "20250307", "listing_expiration_date": "20261231"}