NDC 10337-153

PANDEL

Hydrocortisone Probutate

PANDEL 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 Hydrocortisone Probutate.

• Product ID: 10337-153_25839daf-b70b-4191-a1f5-1a9a53749d34
• NDC: 10337-153
• Product Type: Human Prescription Drug
• Proprietary Name: PANDEL
• Generic Name: Hydrocortisone Probutate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 1997-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA020453
• Labeler Name: PharmaDerm a division of Fougera Pharmaceuticals Inc.
• Substance Name: HYDROCORTISONE PROBUTATE
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 10337-153-66

6 TUBE in 1 CARTON (10337-153-66) > 2 g in 1 TUBE

• Marketing Start Date: 1997-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10337-153-46 [10337015346]

PANDEL CREAM

• Marketing Category: NDA
• Application Number: NDA020453
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-02-28

NDC 10337-153-15 [10337015315]

PANDEL CREAM

• Marketing Category: NDA
• Application Number: NDA020453
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-02-28
• Marketing End Date: 2015-07-14

NDC 10337-153-66 [10337015366]

PANDEL CREAM

• Marketing Category: NDA
• Application Number: NDA020453
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-02-28

NDC 10337-153-80 [10337015380]

PANDEL CREAM

• Marketing Category: NDA
• Application Number: NDA020453
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1997-02-28

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE PROBUTATE	1 mg/g

OpenFDA Data

• SPL SET ID: 361338e6-d719-4bea-aca0-7dd591fcfa08
• Manufacturer:
  • PharmaDerm a division of Fougera Pharmaceuticals Inc.
• UNII:
  • O6550D6K3A
• RxNorm Concept Unique ID - RxCUI:
  • 1370748
  • 1370746

Pharmacological Class

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

NDC Crossover Matching brand name "PANDEL" or generic name "Hydrocortisone Probutate"

NDC	Brand Name	Generic Name
10337-153	PANDEL	HYDROCORTISONE PROBUTATE
62559-325	PANDEL	Hydrocortisone Probutate