FDA.reportPublic FDA data

Fesoterodine Fumarate

Product NDC
67877-068
11-digit product format
678770068
Labeler code
67877
Product ID
67877-068_2fa76e78-8cb1-49ad-8f23-83ce759112be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA204827
Marketing category
ANDA
Marketing start
2022-06-09
Substance
FESOTERODINE FUMARATE
Active strength
8 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
A204827-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2015-12-10
A204827-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2015-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204827-001AB
A204827-002AB

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 22:54:322026-06A204827-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2015-12-10a50c72e98297…
2026-08-01 22:54:322026-06A204827-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2015-12-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204827-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204827-002AB1a50c72e98297…

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 FUMARATEAscend Laboratories, LLCb1abd9cb-c480-437b-8531-e2de3e1883632026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204827
application number: ANDA204827
ndc (product): 67877-068

Additional Listing Data#

Finished product
Yes
Brand name base
Fesoterodine Fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FESOTERODINE FUMARATE8 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
b1abd9cb-c480-437b-8531-e2de3e188363Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
929b9598-46e7-5b66-7a86-5544524fb173Product name620240208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-068-30Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE308
67877-068-90Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-068-30EA - Each67877-068f9eca8a1-176d-43a5-900e-a6015372f8e712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-068FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 2 package rows20240906_b1abd9cb-c480-437b-8531-e2de3e188363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNb1abd9cb-c480-437b-8531-e2de3e1883638
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNb1abd9cb-c480-437b-8531-e2de3e1883638
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDb1abd9cb-c480-437b-8531-e2de3e1883638
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDb1abd9cb-c480-437b-8531-e2de3e1883638
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYb1abd9cb-c480-437b-8531-e2de3e1883638
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYb1abd9cb-c480-437b-8531-e2de3e1883638

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-068-306787700683030 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-30) 2022-06-090000-00-00NoNoCurrent
67877-068-906787700689090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-90) 2022-06-090000-00-00NoNoCurrent