NDC 68788-7091

PROCTOZONE-HC

Hydrocortisone 2.5%

PROCTOZONE-HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Hydrocortisone.

• Product ID: 68788-7091_19341ed2-a9a2-4686-bf50-3955e1659e46
• NDC: 68788-7091
• Product Type: Human Prescription Drug
• Proprietary Name: PROCTOZONE-HC
• Generic Name: Hydrocortisone 2.5%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-02-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040879
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: HYDROCORTISONE
• Active Ingredient Strength: 25 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68788-7091-3

1 TUBE in 1 CARTON (68788-7091-3) > 30 g in 1 TUBE

• Marketing Start Date: 2018-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7091-3 [68788709103]

PROCTOZONE-HC CREAM

• Marketing Category: ANDA
• Application Number: ANDA040879
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-12
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE	25 mg/g

OpenFDA Data

• SPL SET ID: 5f055f94-b213-431b-897e-1c439660f158
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 1440936
  • 310891

Pharmacological Class

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

NDC Crossover Matching brand name "PROCTOZONE-HC" or generic name "Hydrocortisone 2.5%"

NDC	Brand Name	Generic Name
63629-2396	PROCTOZONE-HC	hydrocortisone 2.5%
63629-8847	PROCTOZONE-HC	hydrocortisone 2.5%
64980-324	PROCTOZONE-HC	hydrocortisone 2.5%
68071-2807	PROCTOZONE-HC	hydrocortisone 2.5%
68788-7091	PROCTOZONE-HC	Hydrocortisone 2.5%