Detrol

Product NDC
0009-4544
11-digit product format
000094544
Labeler code
0009
Product ID
0009-4544_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
2 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-4544-01EA - Each0009-4544f90b45ed-b3d2-4097-b7a9-90da030d137012012-07-24
0009-4544-02EA - Each0009-454486683184-dd0a-4755-af47-cf857ec2d6c012012-07-24
0009-4544-03EA - Each0009-45440adf9068-3194-4d73-920c-92a347c76f8812012-07-24

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
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-4544DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]16Legacy NDC20240806_42f819c9-4108-4ca7-92c5-a213037dd4db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855195Detrol 2 MG Oral TabletPSNfa938543-29b3-46ce-a176-5563bc8f2f801
855194tolterodine tartrate 2 MG Oral TabletPSNfa938543-29b3-46ce-a176-5563bc8f2f801
855195tolterodine tartrate 2 MG Oral Tablet [Detrol]SBDfa938543-29b3-46ce-a176-5563bc8f2f801
855194tolterodine tartrate 2 MG Oral TabletSCDfa938543-29b3-46ce-a176-5563bc8f2f801
855195Detrol 2 MG Oral TabletSYfa938543-29b3-46ce-a176-5563bc8f2f801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-4544-020000945440260 TABLET, FILM COATED in 1 BOTTLE (0009-4544-02) 1998-03-250000-00-00NoNoCurrent
0009-4544-0300009454403500 TABLET, FILM COATED in 1 BOTTLE (0009-4544-03) 1998-03-250000-00-00NoNoCurrent