FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
51079-197
11-digit product format
510790197
Labeler code
51079
Product ID
51079-197_9bca909f-8a50-70e4-e053-2995a90a3f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA201486
Marketing category
ANDA
Marketing start
2014-01-28
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
2021-12-31
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 productproduct51079-197DDiscontinued by firm2026-07-31
excluded packagepackage51079-19751079-197-03DDiscontinued 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
51079-197-01EA - Each51079-197c2f231af-e91c-4d1c-aa9d-d9e325026b4712014-05-02
51079-197-03EA - Each51079-19752f0c37b-4050-434d-a41f-66199a434da612014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-197-035107901970330 BLISTER PACK in 1 CARTON (51079-197-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-197-01) 30 blister pack2014-01-280000-00-00NoNoCurrent