Fesoterodine fumarate

Product NDC
51407-661
11-digit product format
514070661
Labeler code
51407
Product ID
51407-661_46435eb8-96be-c2df-e063-6294a90acc78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204975
Marketing category
ANDA
Marketing start
2019-08-13
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
51407-661-30Fesoterodine fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-661-30EA - Each51407-66135e65f5f-77b0-4621-8574-4090b74b38aa12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-661FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, Legacy NDC, 1 package rows20250101_e5e6e146-d39a-471c-e053-2995a90a7538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNe5e6e146-d39a-471c-e053-2995a90a75383
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNe5e6e146-d39a-471c-e053-2995a90a75383
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDe5e6e146-d39a-471c-e053-2995a90a75383
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDe5e6e146-d39a-471c-e053-2995a90a75383
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYe5e6e146-d39a-471c-e053-2995a90a75383
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYe5e6e146-d39a-471c-e053-2995a90a75383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-661-305140706613030 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-661-30) 2022-07-070000-00-00NoNoCurrent