FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
71610-002
11-digit product format
716100002
Labeler code
71610
Product ID
71610-002_8224333e-9d55-4cdc-a69c-dd2a5da74c05
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
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-002DDiscontinued by firm2026-07-31
excluded packagepackage71610-00271610-002-30DDiscontinued 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
71610-002-30EA - Each71610-002190ed2e5-b783-4765-b5a5-234555dfea0f12018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-002-307161000023030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-002-30) 2017-08-030000-00-00NoNoCurrent