Fesoterodine Fumarate

Product NDC
67877-064
11-digit product format
678770064
Labeler code
67877
Product ID
67877-064_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
4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiEOS72165S7
Rxcui810071, 810077

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
67877-064-30Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE308
67877-064-90Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-064-30EA - Each67877-0647f915937-a1cf-41fe-aec9-17ad6c170f0512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-064FESOTERODINE 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
67877-064-306787700643030 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-30) 2022-06-090000-00-00NoNoCurrent
67877-064-906787700649090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90) 2022-06-090000-00-00NoNoCurrent