ApexiCon E

Product NDC
10337-395
11-digit product format
103370395
Labeler code
10337
Product ID
10337-395_4fb98ddc-15ed-4f7f-b334-e64a89aa82dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diflorasone diacetate
Dosage form
CREAM
Route
TOPICAL
Labeler
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application
ANDA076263
Marketing category
ANDA
Marketing start
2002-12-20
Marketing end
2023-04-28
Substance
DIFLORASONE DIACETATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-395-30GM - Gram10337-395607f70b8-c7de-4079-a1dd-1938828ff38712013-03-03
10337-395-60GM - Gram10337-3958dc961fc-47e0-433e-9559-db30eb3d584512013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10337-395-08103370395082 g in 1 TUBE (10337-395-08) 2 g2002-12-202023-01-30NoNoCurrent
10337-395-30103370395301 TUBE in 1 CARTON (10337-395-30) > 30 g in 1 TUBE1 tube2002-12-202023-04-28NoNoCurrent
10337-395-60103370395601 TUBE in 1 CARTON (10337-395-60) > 60 g in 1 TUBE1 tube2002-12-202023-04-28NoNoCurrent
10337-395-66103370395666 TUBE in 1 CARTON (10337-395-66) > 2 g in 1 TUBE6 tube2002-12-202023-01-30NoNoCurrent