FDA.reportPublic FDA data

Detrol LA

Product NDC
55154-3935
11-digit product format
551543935
Labeler code
55154
Product ID
55154-3935_aea9002b-1e7e-4b23-b6d5-5980be46e76b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
NDA021228
Marketing category
NDA
Marketing start
2000-12-22
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
2019-12-31
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 productproduct55154-3935DDiscontinued by firm2026-07-31
excluded packagepackage55154-393555154-3935-0DDiscontinued 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
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…