Azelaic Acid

Product NDC
0115-1624
11-digit product format
001151624
Labeler code
0115
Product ID
0115-1624_8adcda98-4dc1-4379-84b8-c16b122c16d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelaic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA208724
Marketing category
ANDA
Marketing start
2018-11-19
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1624-56GM - Gram0115-1624ac777ed6-0102-48d1-959a-1df86432350c12018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1624-56001151624561 TUBE in 1 CARTON (0115-1624-56) > 50 g in 1 TUBE1 tube2018-11-190000-00-00NoNoCurrent