calcipotriene and betamethasone dipropionate

Product NDC
63646-040
11-digit product format
636460040
Labeler code
63646
Product ID
63646-040_ca89ea13-a8e1-48bb-ab0a-085891d272bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene and betamethasone dipropionate
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
TOLMAR Inc.
Application
ANDA210765
Marketing category
ANDA
Marketing start
2020-05-11
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength
1 mg/g; ug/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Vitamin D [CS],Vitamin D Analog [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63646-040-12GM - Gram63646-040511898a9-148d-4090-a62e-a7b8a221742a12020-06-05
63646-040-60GM - Gram63646-040ebe9c549-c4e9-415c-a074-bded77ccffcb12020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63646-040-12636460040122 BOTTLE in 1 CARTON (63646-040-12) > 60 g in 1 BOTTLE2 bottle2020-05-110000-00-00NoNoCurrent
63646-040-60636460040601 BOTTLE in 1 CARTON (63646-040-60) > 60 g in 1 BOTTLE1 bottle2020-05-110000-00-00NoNoCurrent