Tolterodine Tartrate

Product NDC
43353-346
11-digit product format
433530346
Labeler code
43353
Product ID
43353-346_524fb34f-a4ef-46ca-88b2-15c93ae7cc1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201486
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-346-30EA - Each43353-346b4142f91-c647-442b-b311-cf756a42af2912017-12-14
43353-346-60EA - Each43353-3460b70e926-c096-49fd-b9b9-13cd93e8bfff12017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-346-304335303463030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-346-30) 2017-07-190000-00-00NoNoCurrent
43353-346-604335303466090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-346-60) 2017-07-190000-00-00NoNoCurrent