Trulance

Product NDC
70194-003
11-digit product format
701940003
Labeler code
70194
Product ID
70194-003_c57a7f88-c77b-4921-b601-af7e68903435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plecanatide
Dosage form
TABLET
Route
ORAL
Labeler
Synergy Pharmaceuticals Inc.
Application
NDA208745
Marketing category
NDA
Marketing start
2017-02-21
Marketing end
0000-00-00
Substance
PLECANATIDE
Active strength
3 mg/1
Pharmacologic classes
Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70194-003-30EA - Each70194-00340bdd186-c076-4915-9e86-9c44db1a3c3412017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70194-003-30701940003301 BLISTER PACK in 1 CARTON (70194-003-30) > 30 TABLET in 1 BLISTER PACK1 blister pack2017-02-210000-00-00NoNoCurrent