NDC 64980-329

Fluocinolone Acetonide Oil

Fluocinolone Acetonide Oil

Fluocinolone Acetonide Oil is a Auricular (otic) Oil in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Fluocinolone Acetonide.

• Product ID: 64980-329_9e46bc4c-2918-4b0c-8127-25c5778ca82b
• NDC: 64980-329
• Product Type: Human Prescription Drug
• Proprietary Name: Fluocinolone Acetonide Oil
• Generic Name: Fluocinolone Acetonide Oil
• Dosage Form: Oil
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2016-09-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203378
• Labeler Name: Rising Pharmaceuticals, Inc.
• 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: 2020-12-31

Packaging

NDC 64980-329-20

20 mL in 1 BOTTLE (64980-329-20)

• Marketing Start Date: 2016-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64980-329-20 [64980032920]

Fluocinolone Acetonide Oil OIL

• Marketing Category: ANDA
• Application Number: ANDA203378
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-14

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINOLONE ACETONIDE	.11 mg/mL

OpenFDA Data

• SPL SET ID: 79591576-1eab-48c5-b0a6-e205b3cc097e
• Manufacturer:
  • Rising Pharmaceuticals, Inc.
• UNII:
  • 0CD5FD6S2M
• RxNorm Concept Unique ID - RxCUI:
  • 1191299
• UPC Code:
  • 0364980329200

Pharmacological Class

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

Medicade Reported Pricing

64980032920 FLUOCINOLONE OIL 0.01% EAR DRP

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Fluocinolone Acetonide Oil" or generic name "Fluocinolone Acetonide Oil"

NDC	Brand Name	Generic Name
64980-330	Fluocinolone Acetonide Oil	Fluocinolone Acetonide Oil
64980-331	Fluocinolone Acetonide Oil	Fluocinolone Acetonide Oil
64980-329	Fluocinolone Acetonide	Fluocinolone Acetonide Oil