Finacea

Product NDC
50222-505
11-digit product format
502220505
Labeler code
50222
Product ID
50222-505_be4ce27a-2c6d-4d04-880f-d18cf79b685e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelaic acid
Dosage form
GEL
Route
TOPICAL
Labeler
LEO Pharma Inc.
Application
NDA021470
Marketing category
NDA
Marketing start
2002-12-24
Marketing end
0000-00-00
Substance
AZELAIC ACID
Active strength
0 g/g
Pharmacologic classes
Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-505-50GM - Gram50222-505d7a79dd0-f993-46a7-94b2-b733136a12b012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50222-505FINACEA (AZELAIC ACID) GEL [LEO PHARMA INC.]11Legacy NDC20240126_bea1957c-55ca-48cd-8cbc-ed44d546a857.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50222-505-50502220505501 TUBE in 1 CARTON (50222-505-50) > 50 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent
50222-505-91502220505911 TUBE in 1 CARTON (50222-505-91) > 3 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent