FDA.reportPublic FDA data

Detrol LA

Product NDC
55289-132
Requested package NDC
55289-132-30
11-digit product format
552890132
Labeler code
55289
Product ID
55289-132_d92dd014-2f1a-1f9a-e053-2a95a90a6b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55289-13255289-132-30DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-132-21EA - Each55289-1324be52547-0c7f-435b-bc09-c7d9c8cde72112012-07-24
55289-132-30EA - Each55289-1328abcbef9-aeaa-4fe7-be79-d3b2d014027e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-132-305528901323030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-132-30) 2011-09-280000-00-00NoNoCurrent