FDA.reportPublic FDA data

Detrol

Product NDC
0009-4541
11-digit product format
000094541
Labeler code
0009
Product ID
0009-4541_75d531d1-9683-4809-ab23-7f7872928085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA020771
Marketing category
NDA
Marketing start
1998-03-25
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct0009-4541DDiscontinued by firm2026-07-31
excluded packagepackage0009-45410009-4541-01DDiscontinued by firm2026-07-31
excluded packagepackage0009-45410009-4541-02DDiscontinued by firm2026-07-31
excluded packagepackage0009-45410009-4541-03DDiscontinued 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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-4541-01EA - Each0009-454119af1264-dab2-48d1-b72d-09594ed56a6e12012-07-24
0009-4541-02EA - Each0009-45419fcbc2ff-b893-4424-a7ca-12e039ffb3a612012-07-24
0009-4541-03EA - Each0009-45413240b8de-17b5-4e8d-9dab-3dfb76fe2cd412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
TOLTERODINEACTIVE MOIETYWHE7A56U7KDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-4541DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]16Legacy NDC20240806_42f819c9-4108-4ca7-92c5-a213037dd4db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-4541-020000945410260 TABLET, FILM COATED in 1 BOTTLE (0009-4541-02) 1998-03-250000-00-00NoNoCurrent