83021-750 NDC - ANUBISMED (HA HYALURONIC)

Drug Information

Product NDC: 83021-750

Proprietary Name: ANUBISMED

Non Proprietary Name: HA HYALURONIC

Active Ingredient(s):
  • .198 g/50mL 1,2-HEXANEDIOL;
  • .05 g/50mL ALLANTOIN;
  • 2.5 g/50mL ALOE VERA LEAF;
  • .0535 g/50mL BUTYLATED HYDROXYTOLUENE;
  • 2.25 g/50mL C12-20 ACID PEG-8 ESTER;
  • .198 g/50mL CAPRYLYL GLYCOL;
  • .25 g/50mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE;
  • 1.75 g/50mL CETEARYL ETHYLHEXANOATE;
  • .0038 g/50mL CETYL ALCOHOL;
  • 1.9996 g/50mL DECYL OLEATE;
  • .25 g/50mL DIMETHICONE;
  • .225 g/50mL FRAGRANCE 13576;
  • .4975 g/50mL GLYCERIN;
  • .875 g/50mL GLYCERYL MONOSTEARATE;
  • 1.5 g/50mL GLYCERYL STEARATE SE;
  • .15 g/50mL IMIDUREA;
  • 1.5 g/50mL MEDIUM-CHAIN TRIGLYCERIDES;
  • 3.4965 g/50mL OCTINOXATE;
  • 2 g/50mL OXYBENZONE;
  • 1.996 g/50mL PROPYLENE GLYCOL;
  • .0004 g/50mL TOCOPHEROL;
  • .3 g/50mL TROLAMINE;
  • .004 g/50mL TROPOLONE;
  • 27.4065 mL/50mL WATER


Administration Route(s): TOPICAL

Dosage Form(s): CREAM

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Glycerol [CS];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Chemical Allergen [EPC];
  • Skin Barrier Activity [PE];
  • Standardized Chemical Allergen [EPC]

Labeler Information

Labeler Name: ANUBIS COSMETICS SL
Product Type: HUMAN OTC DRUG
FDA Application Number: M016
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/17/2022

Package Information

No. Package Code Package Description Billing Unit
183021-750-5050 mL in 1 JAR (83021-750-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83021-750The 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 NAMEHA HYALURONICThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe 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 DATE10/17/2022This 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 NUMBERM016This 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 NAME1,2-HEXANEDIOL; ALLANTOIN; ALOE VERA LEAF; BUTYLATED HYDROXYTOLUENE; C12-20 ACID PEG-8 ESTER; CAPRYLYL GLYCOL; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CETEARYL ETHYLHEXANOATE; CETYL ALCOHOL; DECYL OLEATE; DIMETHICONE; FRAGRANCE 13576; GLYCERIN; GLYCERYL MONOSTEARATE; GLYCERYL STEARATE SE; IMIDUREA; MEDIUM-CHAIN TRIGLYCERIDES; OCTINOXATE; OXYBENZONE; PROPYLENE GLYCOL; TOCOPHEROL; TROLAMINE; TROPOLONE; 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 STRENGTH.198; .05; 2.5; .0535; 2.25; .198; .25; 1.75; .0038; 1.9996; .25; .225; .4975; .875; 1.5; .15; 1.5; 3.4965; 2; 1.996; .0004; .3; .004; 27.4065 
ACTIVE INGRED UNITg/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC] 

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