FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-346DDiscontinued by firm2026-07-31
excluded packagepackage43353-34643353-346-30DDiscontinued by firm2026-07-31
excluded packagepackage43353-34643353-346-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201486-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORAL2013-10-31
A201486-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORAL2013-10-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201486-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORAL2013-10-31a50c72e98297…
2026-08-01 22:54:322026-06A201486-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORAL2013-10-31a50c72e98297…

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