AnubisMed

Product NDC
83021-402
11-digit product format
830210402
Labeler code
83021
Product ID
83021-402_049fca13-6921-d895-e063-6294a90a42da
Type
HUMAN OTC DRUG
Nonproprietary name
Azelaic Acid, Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-26
Marketing end
2027-09-08
Substance
ALCOHOL; AZELAIC ACID; ISOPROPYL ALCOHOL; POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; SALICYLIC ACID; WATER
Active strength
22.68; 7; 2.7; 4.9965; 10; 1; 1.62 mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL
Pharmacologic classes
Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AnubisMed

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL22.68 mL/50mL
AZELAIC ACID7 g/50mL
ISOPROPYL ALCOHOL2.7 g/50mL
POLYETHYLENE GLYCOL 4004.9965 g/50mL
PROPYLENE GLYCOL10 g/50mL
SALICYLIC ACID1 g/50mL
WATER1.62 mL/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M, F2VW3D43YT, ND2M416302, B697894SGQ, 6DC9Q167V3, O414PZ4LPZ, 059QF0KO0R

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-402-50AnubisMed50 mL in 1 BOTTLE, GLASSLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-402ANUBISMED (AZELAIC ACID, SALICYLIC ACID) LIQUID [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_ebf3153d-30f5-54e4-e053-2995a90a74b1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-402-508302104025050 mL in 1 BOTTLE, GLASS (83021-402-50) 50 ml2022-10-262027-09-08NoNoCurrent