0037-6824 NDC - EPIFOAM (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE)

Drug Information

Product NDC: 0037-6824

Proprietary Name: EPIFOAM

Non Proprietary Name: pramoxine hydrochloride and hydrocortisone acetate

Active Ingredient(s):
  • 100 mg/10g HYDROCORTISONE ACETATE;
  • 100 mg/10g PRAMOXINE HYDROCHLORIDE


Administration Route(s): TOPICAL

Dosage Form(s): AEROSOL, FOAM

Pharmacy Class(es):
  • Corticosteroid Hormone Receptor Agonists [MoA];
  • Corticosteroid [EPC]

Labeler Information

Labeler Name: Meda Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA086457
Marketing Category: ANDA
Start Marketing Date:8/25/2014

Package Information

No. Package Code Package Description Billing Unit
10037-6824-101 CANISTER in 1 CARTON (0037-6824-10) > 10 g in 1 CANISTERGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC0037-6824The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEEPIFOAMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEpramoxine hydrochloride and hydrocortisone acetateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEAEROSOL, FOAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/25/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA086457This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMeda PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEThe following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH100; 100 
ACTIVE INGRED UNITmg/10g; mg/10g 
PHARM CLASSESCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] 

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This page was last updated on: 9/15/2022