CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

Product NDC
0781-7165
11-digit product format
007817165
Labeler code
0781
Product ID
0781-7165_b85f9bc8-280a-4fb8-9094-a0a30545fc08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene and betamethasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sandoz Inc.
Application
ANDA201615
Marketing category
ANDA
Marketing start
2014-03-31
Marketing end
0000-00-00
Substance
CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE
Active strength
50 ug/g; mg/g
Pharmacologic classes
Vitamin D [CS],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
0781-7165-35GM - Gram0781-716522897379-6fef-43c9-ba6b-7f404bbfba4212014-05-02
0781-7165-95GM - Gram0781-716560341983-3cfc-4ffc-bfa6-387d4750c84a12014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-7165-35007817165351 TUBE in 1 CARTON (0781-7165-35) > 60 g in 1 TUBE1 tube2014-03-310000-00-00NoNoCurrent
0781-7165-95007817165951 TUBE in 1 CARTON (0781-7165-95) > 100 g in 1 TUBE1 tube2014-03-310000-00-00NoNoCurrent