FDA.reportPublic FDA data

Fesoterodine Fumarate

Product NDC
62559-376
11-digit product format
625590376
Labeler code
62559
Product ID
62559-376_31d5e1bf-b31b-4f4b-96ab-11a164a890ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine Fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA204504
Marketing category
ANDA
Marketing start
2023-01-04
Marketing end
0000-00-00
Substance
FESOTERODINE FUMARATE
Active strength
8 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
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 productproduct62559-376DDiscontinued by firm2026-07-31
excluded packagepackage62559-37662559-376-30DDiscontinued 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
A204504-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORAL2023-01-04
A204504-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORAL2023-01-04

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 22:54:322026-06A204504-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORAL2023-01-04a50c72e98297…
2026-08-01 22:54:322026-06A204504-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORAL2023-01-04a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-376-30EA - Each62559-3762ed8aebc-8d7e-4d85-ba61-74bd78f8adb212023-02-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-376-306255903763030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-376-30) 2023-01-040000-00-00NoNoCurrent