NDC 64980-324

PROCTOZONE-HC

Hydrocortisone 2.5%

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

• Product ID: 64980-324_a9b749da-c294-4f95-9883-138f914a8ad9
• NDC: 64980-324
• Product Type: Human Prescription Drug
• Proprietary Name: PROCTOZONE-HC
• Generic Name: Hydrocortisone 2.5%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-08-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040879
• Labeler Name: Rising 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: 2022-12-31

Packaging

NDC 64980-324-30

1 TUBE in 1 CARTON (64980-324-30) > 30 g in 1 TUBE

• Marketing Start Date: 2015-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64980-324-30 [64980032430]

PROCTOZONE-HC CREAM

• Marketing Category: ANDA
• Application Number: ANDA040879
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-08-03

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE	25 mg/g

OpenFDA Data

• SPL SET ID: fb5746ff-3ff1-4874-a827-4694133641b9
• Manufacturer:
  • Rising Pharmaceuticals, Inc.
• UNII:
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 1440936
  • 310891

Pharmacological Class

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

Medicade Reported Pricing

64980032430 PROCTOZONE-HC 2.5% CREAM

Pricing Unit: GM | Drug Type:

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%