NDC 21922-004

Desonide Ointment, 0.05%

Desonide Ointment, 0.05%

Desonide Ointment, 0.05% is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is Desonide.

• Product ID: 21922-004_9a3dcc0b-de17-4229-a75d-7fa9d1ef0cea
• NDC: 21922-004
• Product Type: Human Prescription Drug
• Proprietary Name: Desonide Ointment, 0.05%
• Generic Name: Desonide Ointment, 0.05%
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-03-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210998
• Labeler Name: Encube Ethicals Private Limited
• Substance Name: DESONIDE
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 21922-004-04

1 TUBE in 1 CARTON (21922-004-04) > 15 g in 1 TUBE

• Marketing Start Date: 2019-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21922-004-07 [21922000407]

Desonide Ointment, 0.05% OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA210998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-03-20

NDC 21922-004-04 [21922000404]

Desonide Ointment, 0.05% OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA210998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-03-20

Drug Details

Active Ingredients

Ingredient	Strength
DESONIDE	.5 mg/g

OpenFDA Data

• SPL SET ID: 3d4d19d4-e47b-407e-9df4-fed5f3db91b9
• Manufacturer:
  • Encube Ethicals Private Limited
• UNII:
  • J280872D1O
• RxNorm Concept Unique ID - RxCUI:
  • 204135
• UPC Code:
  • 0321922004045
  • 0321922004076

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Desonide Ointment, 0.05%" or generic name "Desonide Ointment, 0.05%"

NDC	Brand Name	Generic Name
21922-004	Desonide Ointment, 0.05%	Desonide Ointment, 0.05%
63629-8481	Desonide Ointment, 0.05%	Desonide Ointment, 0.05%
63629-8482	Desonide Ointment, 0.05%	Desonide Ointment, 0.05%