NDC 64980-331

Fluocinolone Acetonide Oil

Fluocinolone Acetonide

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

• Product ID: 64980-331_235e83a9-f87c-47eb-8548-716f00fe6d90
• NDC: 64980-331
• Product Type: Human Prescription Drug
• Proprietary Name: Fluocinolone Acetonide Oil
• Generic Name: Fluocinolone Acetonide
• Dosage Form: Oil
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203377
• 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 64980-331-04

118.28 mL in 1 BOTTLE (64980-331-04)

• Marketing Start Date: 2016-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64980-331-04 [64980033104]

Fluocinolone Acetonide Oil OIL

• Marketing Category: ANDA
• Application Number: ANDA203377
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-07-18

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINOLONE ACETONIDE	.11 mg/mL

OpenFDA Data

• SPL SET ID: f45b0ef2-1702-4d21-8ac8-774769304595
• Manufacturer:
  • Rising Pharmaceuticals, Inc.
• UNII:
  • 0CD5FD6S2M
• RxNorm Concept Unique ID - RxCUI:
  • 1191307
• UPC Code:
  • 0364980331043

Pharmacological Class

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

Medicade Reported Pricing

64980033104 FLUOCINOLONE 0.01% BODY OIL

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
64980-329	Fluocinolone Acetonide Oil	Fluocinolone Acetonide Oil
64980-330	Fluocinolone Acetonide Oil	Fluocinolone Acetonide Oil
64980-331	Fluocinolone Acetonide Oil	Fluocinolone Acetonide Oil
0299-5500	Capex	fluocinolone acetonide
39328-079	Flac Otic Oil	fluocinolone acetonide
0168-0058	Fluocinolone Acetonide	fluocinolone acetonide
0168-0059	Fluocinolone Acetonide	fluocinolone acetonide
0168-0060	Fluocinolone Acetonide	fluocinolone acetonide
0168-0064	Fluocinolone Acetonide	fluocinolone acetonide
0713-0223	Fluocinolone Acetonide	Fluocinolone Acetonide
0713-0224	Fluocinolone Acetonide	Fluocinolone Acetonide
0713-0324	Fluocinolone Acetonide	Fluocinolone Acetonide
0713-0325	Fluocinolone Acetonide	Fluocinolone Acetonide
0713-0709	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE
10135-670	fluocinolone acetonide	fluocinolone acetonide
13925-506	Fluocinolone Acetonide	fluocinolone acetonide
13925-507	Fluocinolone Acetonide	fluocinolone acetonide
42291-283	Fluocinolone Acetonide	Fluocinolone Acetonide
42291-284	Fluocinolone Acetonide	Fluocinolone Acetonide
42291-285	Fluocinolone Acetonide	Fluocinolone Acetonide
43386-069	Fluocinolone Acetonide	Fluocinolone Acetonide
13925-508	Fluocinolone acetonide 0.01%	fluocinolone acetonide
24208-416	Retisert	Fluocinolone Acetonide
43538-900	Synalar	fluocinolone acetonide
43538-901	Synalar	Fluocinolone acetonide
43538-910	Synalar	fluocinolone acetonide
43538-911	Synalar	Fluocinolone acetonide
43538-920	Synalar	fluocinolone acetonide
43538-921	Synalar TS	fluocinolone acetonide