FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
70518-1416
11-digit product format
705181416
Labeler code
70518
Product ID
70518-1416_e419238d-798d-6acd-e053-2995a90aabe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020771
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-09-17
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
2023-12-31
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 productproduct70518-1416DDiscontinued by firm2026-07-31
excluded packagepackage70518-141670518-1416-0DDiscontinued 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
N020771-001DETROLTOLTERODINE TARTRATE1MGTABLET / ORALABRLD1998-03-25
N020771-002DETROLTOLTERODINE TARTRATE2MGTABLET / ORALABRLD, RS1998-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020771-001AB
N020771-002AB

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 22:54:322026-06N020771-001DETROL1MGTABLET / ORALABRLD1998-03-25a50c72e98297…
2026-08-01 22:54:322026-06N020771-002DETROL2MGTABLET / ORALABRLD, RS1998-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020771-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020771-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEMylan Pharmaceuticals Inc.9e432622-2e6f-4cf8-892f-510288dd50f22024-09-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771
DetrolTOLTERODINE TARTRATEViatris Specialty LLC41eb00d2-64e3-4ec9-8732-4bfc81b041802023-02-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1416-07051814160028 TABLET, FILM COATED in 1 BLISTER PACK (70518-1416-0) 2018-09-170000-00-00NoNoCurrent