NDC 0037-6824

EPIFOAM

Pramoxine Hydrochloride And Hydrocortisone Acetate

EPIFOAM is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Pramoxine Hydrochloride; Hydrocortisone Acetate.

• Product ID: 0037-6824_74d3a7b5-1602-4861-a662-50fe63a9cdfe
• NDC: 0037-6824
• Product Type: Human Prescription Drug
• Proprietary Name: EPIFOAM
• Generic Name: Pramoxine Hydrochloride And Hydrocortisone Acetate
• Dosage Form: Aerosol, Foam
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-08-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086457
• Labeler Name: Meda Pharmaceuticals
• Substance Name: PRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE
• Active Ingredient Strength: 100 mg/10g; mg/10g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0037-6824-10

1 CANISTER in 1 CARTON (0037-6824-10) > 10 g in 1 CANISTER

• Marketing Start Date: 2014-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-6824-10 [00037682410]

EPIFOAM AEROSOL, FOAM

• Marketing Category: ANDA
• Application Number: ANDA086457
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-08-25

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	100 mg/10g

OpenFDA Data

• SPL SET ID: b22b8b41-2f1e-11e4-8c21-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 88AYB867L5
  • 3X7931PO74
• RxNorm Concept Unique ID - RxCUI:
  • 904782
  • 904783
• UPC Code:
  • 0300376824102

Pharmacological Class

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

NDC Crossover Matching brand name "EPIFOAM" or generic name "Pramoxine Hydrochloride And Hydrocortisone Acetate"

NDC	Brand Name	Generic Name
0037-6824	EPIFOAM	pramoxine hydrochloride and hydrocortisone acetate
75834-197	HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE	PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE