Tolterodine Tartrate

Product NDC
0378-3404
11-digit product format
003783404
Labeler code
0378
Product ID
0378-3404_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
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
0378-3404-05EA - Each0378-340461874735-3f4d-4de2-9ad8-bdc10b5b7b0612014-02-04
0378-3404-77EA - Each0378-340432822b0a-6817-4252-8065-c4376224ba1f12014-02-04
0378-3404-93EA - Each0378-3404a76c770c-45a1-4ef1-8f84-1e7b6227ae6312014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3404-0500378340405500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3404-05) 2013-10-310000-00-00NoNoCurrent
0378-3404-930037834049330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3404-93) 2013-10-310000-00-00NoNoCurrent