Tolterodine Tartrate

Product NDC
0378-3402
11-digit product format
003783402
Labeler code
0378
Product ID
0378-3402_03852abe-992e-4d0b-a105-19ca8faba01e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201486
Marketing category
ANDA
Marketing start
2013-10-31
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
2 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
0378-3402-05EA - Each0378-34020f61f691-16e1-4c75-b8f4-a82319e539a312014-02-04
0378-3402-77EA - Each0378-34024c6b84de-06b6-4e7b-83a4-ee6409d634e912014-02-04
0378-3402-93EA - Each0378-34026ccba939-a946-4cea-a96d-e61188d1adab12014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3402-0500378340205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-05) 2013-10-310000-00-00NoNoCurrent
0378-3402-930037834029330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-93) 2013-10-310000-00-00NoNoCurrent