83107-020 NDC - ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE)

Drug Information

  • Product NDC: 83107-020
  • Proprietary Name: Analpram HC
  • Non Proprietary Name: hydrocortisone acetate and pramoxine hydrochloride
  • Active Ingredient(s): 25 mg/mL HYDROCORTISONE ACETATE; 10 mg/mL PRAMOXINE HYDROCHLORIDE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): LOTION
  • Pharmacy Class(es): Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Legacy Pharma USA Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA085979
Marketing Category: ANDA
Start Marketing Date:5/23/2025

Package Information

No. Package Code Package Description Billing Unit
183107-020-0259 mL in 1 BOTTLE, PLASTIC (83107-020-02)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC83107-020The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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 NAMEAnalpram HCThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEhydrocortisone acetate and pramoxine hydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELOTIONThe 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 DATE5/23/2025Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEANDAAn 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.
APPLICATION NUMBERANDA085979 
LABELER NAMELegacy Pharma USA Inc. 
SUBSTANCE NAMEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 
ACTIVE NUMERATOR STRENGTH25; 10 
ACTIVE INGRED UNITmg/mL; mg/mL 
PHARM CLASSESCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] 

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This page was last updated on: 3/6/2026

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