FDA.reportPublic FDA data

Detrol LA

Product NDC
0009-5191
Requested package NDC
0009-5191-03
11-digit product format
000095191
Labeler code
0009
Product ID
0009-5191_54731895-ffd4-4d24-acb1-97fdde96382f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Pharmacia and Upjohn Company LLC
Application
NDA021228
Marketing category
NDA
Marketing start
2000-02-22
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
4 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0009-51910009-5191-03DDiscontinued 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
N021228-001DETROL LATOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22
N021228-002DETROL LATOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021228-001AB
N021228-002AB

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 22:54:322026-06N021228-001DETROL LA2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22a50c72e98297…
2026-08-01 22:54:322026-06N021228-002DETROL LA4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021228-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021228-002AB1a50c72e98297…

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
0009-5191-01EA - Each0009-5191fd61e899-cace-4d73-9af2-0520edbf6ed412012-07-24
0009-5191-02EA - Each0009-5191723b700a-677f-4a91-9637-48930e2e9ba812012-07-24
0009-5191-03EA - Each0009-51919ab8e141-1e19-43f8-88a4-ca688d9f25ab12012-07-24
0009-5191-04EA - Each0009-51919c1fe3e6-fe16-4025-af69-89baf637b50912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
TOLTERODINEACTIVE MOIETYWHE7A56U7KDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
GELATININACTIVE INGREDIENT2G86QN327LDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
SUCROSEINACTIVE INGREDIENTC151H8M554DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]12
tolterodine tartrateACTIVE INGREDIENT5T619TQR3RDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
tolterodineACTIVE MOIETYWHE7A56U7KDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
gelatinINACTIVE INGREDIENT2G86QN327LDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WODETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
oleic acidINACTIVE INGREDIENT2UMI9U37CPDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
sucroseINACTIVE INGREDIENTC151H8M554DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]6
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855184Detrol LA 2 MG 24HR Extended Release Oral CapsulePSN25994fad-388d-4f9c-950e-14b7f8073b8c1
855191Detrol LA 4 MG 24HR Extended Release Oral CapsulePSN25994fad-388d-4f9c-950e-14b7f8073b8c1
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN25994fad-388d-4f9c-950e-14b7f8073b8c1
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN25994fad-388d-4f9c-950e-14b7f8073b8c1
85518424 HR tolterodine tartrate 2 MG Extended Release Oral Capsule [Detrol]SBD25994fad-388d-4f9c-950e-14b7f8073b8c1
85519124 HR tolterodine tartrate 4 MG Extended Release Oral Capsule [Detrol]SBD25994fad-388d-4f9c-950e-14b7f8073b8c1
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD25994fad-388d-4f9c-950e-14b7f8073b8c1
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD25994fad-388d-4f9c-950e-14b7f8073b8c1
85518424 HR Detrol 2 MG Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1
85519124 HR Detrol LA 4 MG Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1
855184Detrol LA 2 MG 24 HR Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1
855191Detrol LA 4 MG 24 HR Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY25994fad-388d-4f9c-950e-14b7f8073b8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-5191-0300009519103500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0009-5191-03) 2000-02-220000-00-00NoNoCurrent