FDA.reportPublic FDA data

Fesoterodine Fumarate

Product NDC
65162-369
11-digit product format
651620369
Labeler code
65162
Product ID
65162-369_84a0cad7-6b3b-46f3-8797-c0b922026154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205002
Marketing category
ANDA
Marketing start
2023-01-06
Substance
FESOTERODINE FUMARATE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A205002-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04
A205002-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205002-001AB
A205002-002AB

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 22:54:322026-06A205002-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04a50c72e98297…
2026-08-01 22:54:322026-06A205002-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205002-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205002-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fesoterodine FumarateFESOTERODINE FUMARATEAmneal Pharmaceuticals LLC1d3fdfcf-7406-4be0-90e9-b10c9257bf692024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205002
application number: ANDA205002
ndc (product): 65162-369

Additional Listing Data#

Finished product
Yes
Brand name base
Fesoterodine Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FESOTERODINE FUMARATE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EOS72165S7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
810071Internal RxNorm lookup
810077Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d3fdfcf-7406-4be0-90e9-b10c9257bf69Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
929b9598-46e7-5b66-7a86-5544524fb173Product name620240208
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-369-03Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
65162-369-09Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-369FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20240514_1d3fdfcf-7406-4be0-90e9-b10c9257bf69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN1d3fdfcf-7406-4be0-90e9-b10c9257bf6912
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN1d3fdfcf-7406-4be0-90e9-b10c9257bf6912
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD1d3fdfcf-7406-4be0-90e9-b10c9257bf6912
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD1d3fdfcf-7406-4be0-90e9-b10c9257bf6912
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY1d3fdfcf-7406-4be0-90e9-b10c9257bf6912
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY1d3fdfcf-7406-4be0-90e9-b10c9257bf6912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-369-036516203690330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03) 2023-01-060000-00-00NoNoCurrent
65162-369-096516203690990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09) 2023-01-060000-00-00NoNoCurrent