NDC 10337-395

ApexiCon E

Diflorasone Diacetate

ApexiCon E is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc.. The primary component is Diflorasone Diacetate.

• Product ID: 10337-395_4b76e279-db54-4f8d-b4b3-f9627a579284
• NDC: 10337-395
• Product Type: Human Prescription Drug
• Proprietary Name: ApexiCon E
• Generic Name: Diflorasone Diacetate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2002-12-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076263
• Labeler Name: PharmaDerm a division of Fougera Pharmaceuticals Inc.
• Substance Name: DIFLORASONE DIACETATE
• 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 10337-395-08

2 g in 1 TUBE (10337-395-08)

• Marketing Start Date: 2002-12-20
• Marketing End Date: 2023-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10337-395-30 [10337039530]

ApexiCon E CREAM

• Marketing Category: ANDA
• Application Number: ANDA076263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2002-12-20

NDC 10337-395-66 [10337039566]

ApexiCon E CREAM

• Marketing Category: ANDA
• Application Number: ANDA076263
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-12-20

NDC 10337-395-60 [10337039560]

ApexiCon E CREAM

• Marketing Category: ANDA
• Application Number: ANDA076263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2002-12-20

NDC 10337-395-08 [10337039508]

ApexiCon E CREAM

• Marketing Category: ANDA
• Application Number: ANDA076263
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-12-20

Drug Details

Active Ingredients

Ingredient	Strength
DIFLORASONE DIACETATE	.5 mg/g

OpenFDA Data

• SPL SET ID: af4c413b-c228-48f0-9ad0-6434d1f921b9
• Manufacturer:
  • PharmaDerm a division of Fougera Pharmaceuticals Inc.
• UNII:
  • 7W2J09SCWX
• RxNorm Concept Unique ID - RxCUI:
  • 966577
  • 966820
• UPC Code:
  • 0310337395602

Pharmacological Class

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

Medicade Reported Pricing

10337039560 APEXICON E 0.05% CREAM

Pricing Unit: GM | Drug Type:

10337039530 APEXICON E 0.05% CREAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "ApexiCon E" or generic name "Diflorasone Diacetate"

NDC	Brand Name	Generic Name
10337-395	ApexiCon E	diflorasone diacetate
62559-365	ApexiCon E	diflorasone diacetate
0168-0242	Diflorasone Diacetate	diflorasone diacetate
0168-0243	Diflorasone Diacetate	Diflorasone Diacetate
0168-0353	Diflorasone Diacetate	diflorasone diacetate
51672-1295	Diflorasone Diacetate	Diflorasone Diacetate
51672-1296	Diflorasone Diacetate	Diflorasone Diacetate
52565-063	Diflorasone Diacetate	Diflorasone Diacetate
61748-350	Diflorasone Diacetate	Diflorasone Diacetate
64980-124	Diflorasone Diacetate	diflorasone diacetate
71800-009	Diflorasone Diacetate	Diflorasone Diacetate
72919-549	Diflorasone Diacetate	Diflorasone Diacetate
51672-5292	psorcon	Diflorasone Diacetate