NDC 57893-311

Nolix

Flurandrenolide

Nolix is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Artesa Labs, Llc. The primary component is Flurandrenolide.

• Product ID: 57893-311_68680024-58c3-1c8c-e053-2991aa0ab55b
• NDC: 57893-311
• Product Type: Human Prescription Drug
• Proprietary Name: Nolix
• Generic Name: Flurandrenolide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-05-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205343
• Labeler Name: Artesa Labs, LLC
• Substance Name: FLURANDRENOLIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57893-311-12

120 mL in 1 BOTTLE (57893-311-12)

• Marketing Start Date: 2017-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57893-311-12 [57893031112]

Nolix LOTION

• Marketing Category: ANDA
• Application Number: ANDA205343
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-22

Drug Details

Active Ingredients

Ingredient	Strength
FLURANDRENOLIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 50212234-8595-0ac7-e054-00144ff8d46c
• Manufacturer:
  • Artesa Labs, LLC
• UNII:
  • 8EUL29XUQT
• RxNorm Concept Unique ID - RxCUI:
  • 197719
  • 1923326
• UPC Code:
  • 0357893311127

Pharmacological Class

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

NDC Crossover Matching brand name "Nolix" or generic name "Flurandrenolide"

NDC	Brand Name	Generic Name
57893-310	Nolix	FLURANDRENOLIDE
57893-311	Nolix	FLURANDRENOLIDE
0023-5870	Cordran	Flurandrenolide
16110-026	Cordran	flurandrenolide
16110-034	Cordran	flurandrenolide
16110-035	Cordran	flurandrenolide
16110-052	Cordran	flurandrenolide
16110-587	CORDRAN	flurandrenolide
24470-921	Flurandrenolide	FLURANDRENOLIDE
45802-928	Flurandrenolide	Flurandrenolide
51672-5298	Flurandrenolide	Flurandrenolide
51672-5301	Flurandrenolide	Flurandrenolide
51862-158	flurandrenolide	flurandrenolide
52565-017	Flurandrenolide	Flurandrenolide
63629-8657	Flurandrenolide	Flurandrenolide
24470-919	Flurandrenolide Cream	FLURANDRENOLIDE