FESOTERODINE FUMARATE

Product NDC
72603-413
11-digit product format
726030413
Labeler code
72603
Product ID
72603-413_2f97f9a3-4f2e-8409-e063-6394a90a7f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FESOTERODINE FUMARATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA204792
Marketing category
ANDA
Marketing start
2024-05-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-413-01FESOTERODINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-413-01EA - Each72603-4138677b9e5-a354-4dc0-bcae-c011b856faf812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-413FESOTERODINE FUMARATE (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RXLLC]2Current NDC, 1 package rows20250308_cb597206-1c75-4a4f-a17a-524a2010a4b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNcb597206-1c75-4a4f-a17a-524a2010a4b92
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNcb597206-1c75-4a4f-a17a-524a2010a4b92
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDcb597206-1c75-4a4f-a17a-524a2010a4b92
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDcb597206-1c75-4a4f-a17a-524a2010a4b92
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYcb597206-1c75-4a4f-a17a-524a2010a4b92
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYcb597206-1c75-4a4f-a17a-524a2010a4b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-413-017260304130130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-413-01) 2024-05-01NoNoCurrent