NDC 70512-034

Fluocinonide Gel

Fluocinonide Gel

Fluocinonide Gel is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Kbs Solutions. The primary component is Fluocinonide.

• Product ID: 70512-034_835a8058-8e21-1e68-e053-2991aa0ad37c
• NDC: 70512-034
• Product Type: Human Prescription Drug
• Proprietary Name: Fluocinonide Gel
• Generic Name: Fluocinonide Gel
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-02-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209030
• Labeler Name: KBS Solutions
• Substance Name: FLUOCINONIDE
• 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 70512-034-60

1 TUBE in 1 CARTON (70512-034-60) > 60 g in 1 TUBE

• Marketing Start Date: 2019-02-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70512-034-60 [70512003460]

Fluocinonide Gel GEL

• Marketing Category: ANDA
• Application Number: ANDA209030
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-02-04

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINONIDE	.5 mg/g

OpenFDA Data

• SPL SET ID: 81aa7142-baeb-6814-e053-2a91aa0ab29c
• Manufacturer:
  • KBS Solutions
• UNII:
  • 2W4A77YPAN
• RxNorm Concept Unique ID - RxCUI:
  • 310362
• UPC Code:
  • 0370512034603

Pharmacological Class

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

NDC Crossover Matching brand name "Fluocinonide Gel" or generic name "Fluocinonide Gel"

NDC	Brand Name	Generic Name
47781-533	Fluocinonide Gel	Fluocinonide Gel
70512-034	Fluocinonide Gel	Fluocinonide Gel