NDC 0168-0353

Diflorasone Diacetate

Diflorasone Diacetate

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

• Product ID: 0168-0353_d1b032e1-b59c-41c4-833b-3808ba6c3b88
• NDC: 0168-0353
• Product Type: Human Prescription Drug
• Proprietary Name: Diflorasone Diacetate
• 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: E. Fougera & Co. 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 0168-0353-30

1 TUBE in 1 CARTON (0168-0353-30) > 30 g in 1 TUBE

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

NDC SPL Data Element Entries

NDC 0168-0353-30 [00168035330]

Diflorasone Diacetate CREAM

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

NDC 0168-0353-60 [00168035360]

Diflorasone Diacetate CREAM

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

NDC 0168-0353-15 [00168035315]

Diflorasone Diacetate CREAM

• Marketing Category: ANDA
• Application Number: ANDA076263
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-12-20
• Marketing End Date: 2012-06-22

Drug Details

Active Ingredients

Ingredient	Strength
DIFLORASONE DIACETATE	.5 mg/g

OpenFDA Data

• SPL SET ID: 40be624a-6acd-4001-9869-446695b9fb61
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • 7W2J09SCWX
• RxNorm Concept Unique ID - RxCUI:
  • 966577

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
10337-395	ApexiCon E	diflorasone diacetate
62559-365	ApexiCon E	diflorasone diacetate
51672-5292	psorcon	Diflorasone Diacetate