desonide ointment, 0.05%

Generic: desonide ointment, 0.05%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desonide ointment, 0.05%
Generic Name desonide ointment, 0.05%
Labeler encube ethicals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

desonide .5 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-004
Product ID 21922-004_545fde77-f6c2-4129-b67f-1f8eadd5efde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210998
Listing Expiration 2027-12-31
Marketing Start 2019-03-20

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 21922004
Hyphenated Format 21922-004

Supplemental Identifiers

UPC
0321922004076 0321922004045
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 ointment, 0.05% (source: ndc)
Generic Name desonide ointment, 0.05% (source: ndc)
Application Number ANDA210998 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE
source: ndc

Packages (2)

21922-004-04 1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE 21922-004-07 1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE

Ingredients (1)

desonide (.5 mg/g)

Linked Drug Pages (1)

Desonide Ointment, 0.05% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "545fde77-f6c2-4129-b67f-1f8eadd5efde", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0321922004076", "0321922004045"], "unii": ["J280872D1O"], "spl_set_id": ["3d4d19d4-e47b-407e-9df4-fed5f3db91b9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-004-04)  / 15 g in 1 TUBE", "package_ndc": "21922-004-04", "marketing_start_date": "20190320"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-004-07)  / 60 g in 1 TUBE", "package_ndc": "21922-004-07", "marketing_start_date": "20190320"}], "brand_name": "Desonide Ointment, 0.05%", "product_id": "21922-004_545fde77-f6c2-4129-b67f-1f8eadd5efde", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-004", "generic_name": "Desonide Ointment, 0.05%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desonide Ointment, 0.05%", "active_ingredients": [{"name": "DESONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA210998", "marketing_category": "ANDA", "marketing_start_date": "20190320", "listing_expiration_date": "20271231"}