83021-402 NDC - ANUBISMED (AZELAIC ACID, SALICYLIC ACID)

Drug Information

Product NDC: 83021-402

Proprietary Name: AnubisMed

Non Proprietary Name: Azelaic Acid, Salicylic Acid

Active Ingredient(s):
  • 22.68 mL/50mL ALCOHOL;
  • 7 g/50mL AZELAIC ACID;
  • 2.7 g/50mL ISOPROPYL ALCOHOL;
  • 4.9965 g/50mL POLYETHYLENE GLYCOL 400;
  • 10 g/50mL PROPYLENE GLYCOL;
  • 1 g/50mL SALICYLIC ACID;
  • 1.62 mL/50mL WATER


Administration Route(s): TOPICAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Decreased Protein Synthesis [PE];
  • Decreased Sebaceous Gland Activity [PE]

Labeler Information

Labeler Name: ANUBIS COSMETICS SL
Product Type: HUMAN OTC DRUG
FDA Application Number: M006
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/26/2022

Package Information

No. Package Code Package Description Billing Unit
183021-402-5050 mL in 1 BOTTLE, GLASS (83021-402-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83021-402The 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 OTC 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 NAMEAnubisMedThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAzelaic Acid, Salicylic AcidThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE10/26/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 NUMBERM006This 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 NAMEANUBIS COSMETICS SLName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALCOHOL; AZELAIC ACID; ISOPROPYL ALCOHOL; POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; SALICYLIC ACID; WATERAn 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 STRENGTH22.68; 7; 2.7; 4.9965; 10; 1; 1.62 
ACTIVE INGRED UNITmL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL 
PHARM CLASSESDecreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE] 

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This page was last updated on: 2/1/2023