NDC 21922-003

Fluocinolone Acetonide Topical Solution USP, 0.01%

Fluocinolone Acetonide Topical Solution Usp, 0.01%

Fluocinolone Acetonide Topical Solution USP, 0.01% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is Fluocinolone Acetonide.

• Product ID: 21922-003_b575b93d-a5a2-8ddd-e053-2995a90a4561
• NDC: 21922-003
• Product Type: Human Prescription Drug
• Proprietary Name: Fluocinolone Acetonide Topical Solution USP, 0.01%
• Generic Name: Fluocinolone Acetonide Topical Solution Usp, 0.01%
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-03-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209913
• Labeler Name: Encube Ethicals Private Limited
• Substance Name: FLUOCINOLONE ACETONIDE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 21922-003-01

1 BOTTLE in 1 CARTON (21922-003-01) > 60 mL in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 21922-003-01 [21922000301]

Fluocinolone Acetonide Topical Solution USP, 0.01% SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209913
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-20

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINOLONE ACETONIDE	.1 mg/mL

OpenFDA Data

• SPL SET ID: 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36
• Manufacturer:
  • Encube Ethicals Private Limited
• UNII:
  • 0CD5FD6S2M
• RxNorm Concept Unique ID - RxCUI:
  • 1191310
• UPC Code:
  • 0321922003017

Pharmacological Class

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

NDC Crossover Matching brand name "Fluocinolone Acetonide Topical Solution USP, 0.01%" or generic name "Fluocinolone Acetonide Topical Solution Usp, 0.01%"

NDC	Brand Name	Generic Name
21922-003	Fluocinolone Acetonide Topical Solution USP, 0.01%	Fluocinolone Acetonide Topical Solution USP, 0.01%
63629-9584	Fluocinolone Acetonide Topical Solution USP, 0.01%	Fluocinolone Acetonide Topical Solution USP, 0.01%