FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
60429-825
11-digit product format
604290825
Labeler code
60429
Product ID
60429-825_933df4cb-0ac8-ef35-e053-2a95a90aae22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, 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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-825DDiscontinued by firm2026-07-31
excluded packagepackage60429-82560429-825-05DDiscontinued by firm2026-07-31
excluded packagepackage60429-82560429-825-30DDiscontinued by firm2026-07-31
excluded packagepackage60429-82560429-825-90DDiscontinued 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
60429-825-05EA - Each60429-825371f39c3-ebaf-486e-af8d-ec76a77b06ed12017-04-05
60429-825-30EA - Each60429-8259954321e-8f07-4eab-a5c7-7d3567b35ff912017-04-05
60429-825-90EA - Each60429-8253690a5c2-c864-4e40-ae22-932555dc8ac412017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-825-0560429082505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60429-825-05) 2016-07-210000-00-00NoNoCurrent
60429-825-306042908253030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60429-825-30) 2016-07-210000-00-00NoNoCurrent
60429-825-906042908259090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60429-825-90) 2016-07-210000-00-00NoNoCurrent