NDC 52565-013

Fluocinolone Acetonide

Fluocinolone Acetonide

Fluocinolone Acetonide is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Fluocinolone Acetonide.

• Product ID: 52565-013_e619899e-3d8d-480b-a66d-49cbc9543f17
• NDC: 52565-013
• Product Type: Human Prescription Drug
• Proprietary Name: Fluocinolone Acetonide
• Generic Name: Fluocinolone Acetonide
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-12-27
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA013960
• Labeler Name: Teligent Pharma, Inc.
• Substance Name: FLUOCINOLONE ACETONIDE
• Active Ingredient Strength: 0 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52565-013-15

1 TUBE in 1 CARTON (52565-013-15) > 15 g in 1 TUBE

• Marketing Start Date: 2012-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52565-013-15 [52565001315]

Fluocinolone Acetonide OINTMENT

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA013960
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-12-27

NDC 52565-013-60 [52565001360]

Fluocinolone Acetonide OINTMENT

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA013960
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-12-27

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINOLONE ACETONIDE	.25 mg/g

OpenFDA Data

• SPL SET ID: dbf0ae16-5180-4397-9012-7e5181074511
• Manufacturer:
  • Teligent Pharma, Inc.
• UNII:
  • 0CD5FD6S2M
• RxNorm Concept Unique ID - RxCUI:
  • 1191256

Pharmacological Class

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

Medicade Reported Pricing

52565001360 FLUOCINOLONE 0.025% OINTMENT

Pricing Unit: GM | Drug Type:

52565001315 FLUOCINOLONE 0.025% OINTMENT

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
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
68462-185	fluocinolone acetonide	fluocinolone acetonide
68462-591	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE
68462-590	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE
71428-002	Fluocinolone Acetonide	Fluocinolone Acetonide
45802-485	Fluocinolone acetonide	Fluocinolone acetonide
45802-887	fluocinolone acetonide	fluocinolone acetonide
45802-009	Fluocinolone Acetonide	Fluocinolone Acetonide
51672-1365	Fluocinolone Acetonide	Fluocinolone Acetonide
51672-1356	Fluocinolone Acetonide	Fluocinolone Acetonide
51672-1357	Fluocinolone Acetonide	Fluocinolone Acetonide
52565-012	Fluocinolone Acetonide	Fluocinolone Acetonide
52565-020	Fluocinolone Acetonide	Fluocinolone Acetonide
52565-013	Fluocinolone Acetonide	Fluocinolone Acetonide
52565-031	Fluocinolone Acetonide	Fluocinolone Acetonide
61748-204	Fluocinolone Acetonide	Fluocinolone Acetonide
61748-250	Fluocinolone Acetonide	Fluocinolone Acetonide
65162-702	Fluocinolone Acetonide	Fluocinolone Acetonide
65162-704	Fluocinolone Acetonide	Fluocinolone Acetonide
65162-703	Fluocinolone Acetonide	Fluocinolone Acetonide
0299-5500	Capex	fluocinolone acetonide
39328-079	Flac Otic Oil	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