NDC 0037-6822

PROCTOFOAM HC

Pramoxine Hydrochloride Hydrocortisone Acetate

PROCTOFOAM HC 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: 0037-6822_373db040-937c-4208-b1ba-55e874b2ff2a
• NDC: 0037-6822
• Product Type: Human Prescription Drug
• Proprietary Name: PROCTOFOAM HC
• Generic Name: Pramoxine Hydrochloride Hydrocortisone Acetate
• Dosage Form: Aerosol, Foam
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-08-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086195
• 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: 2021-12-31

Packaging

NDC 0037-6822-10

1 CANISTER in 1 CARTON (0037-6822-10) > 10 g in 1 CANISTER

• Marketing Start Date: 2014-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-6822-10 [00037682210]

PROCTOFOAM HC AEROSOL, FOAM

• Marketing Category: ANDA
• Application Number: ANDA086195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-08-15

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	100 mg/10g

OpenFDA Data

• SPL SET ID: 3831e931-ec0a-11e3-ac10-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 88AYB867L5
  • 3X7931PO74
• RxNorm Concept Unique ID - RxCUI:
  • 828362
  • 828364
• UPC Code:
  • 0300376822108

Pharmacological Class

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

NDC Crossover Matching brand name "PROCTOFOAM HC" or generic name "Pramoxine Hydrochloride Hydrocortisone Acetate"

NDC	Brand Name	Generic Name
21695-982	Proctofoam HC	Proctofoam HC
0037-6822	PROCTOFOAM	pramoxine hydrochloride hydrocortisone acetate