NDC 71403-804

Cloderm

Clocortolone Pivalate

Cloderm is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Epi Health, Inc. The primary component is Clocortolone Pivalate.

• Product ID: 71403-804_30f99cc9-3f41-462a-90c5-e1769cfb8f66
• NDC: 71403-804
• Product Type: Human Prescription Drug
• Proprietary Name: Cloderm
• Generic Name: Clocortolone Pivalate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-10-30
• Marketing Category: NDA / NDA
• Application Number: NDA017765
• Labeler Name: EPI Health, Inc
• Substance Name: CLOCORTOLONE PIVALATE
• 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 71403-804-23

2 g in 1 TUBE (71403-804-23)

• Marketing Start Date: 2018-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71403-804-23 [71403080423]

Cloderm CREAM

• Marketing Category: NDA
• Application Number: NDA017765
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-30

NDC 71403-804-75 [71403080475]

Cloderm CREAM

• Marketing Category: NDA
• Application Number: NDA017765
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-10-30

NDC 71403-804-90 [71403080490]

Cloderm CREAM

• Marketing Category: NDA
• Application Number: NDA017765
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-10-30

NDC 71403-804-48 [71403080448]

Cloderm CREAM

• Marketing Category: NDA
• Application Number: NDA017765
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-30
• Marketing End Date: 2019-09-13

NDC 71403-804-45 [71403080445]

Cloderm CREAM

• Marketing Category: NDA
• Application Number: NDA017765
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-10-30

Drug Details

Active Ingredients

Ingredient	Strength
CLOCORTOLONE PIVALATE	1 mg/g

OpenFDA Data

• SPL SET ID: a8f6ef34-471c-4f30-961b-08cb777a7cd8
• Manufacturer:
  • EPI Health, Inc
• UNII:
  • QBL8IZH14X
• RxNorm Concept Unique ID - RxCUI:
  • 206048
  • 197520

Pharmacological Class

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

NDC Crossover Matching brand name "Cloderm" or generic name "Clocortolone Pivalate"

NDC	Brand Name	Generic Name
67857-804	Cloderm	clocortolone pivalate
71403-804	Cloderm	clocortolone pivalate
43598-341	clocortolone pivalate	clocortolone pivalate
51672-4166	Clocortolone Pivalate	Clocortolone Pivalate
66993-947	Clocortolone Pivalate Cream	Clocortolone Pivalate