FDA.reportPublic FDA data

Fesoterodine fumarate

Product NDC
43598-248
11-digit product format
435980248
Labeler code
43598
Product ID
43598-248_fb4f7798-3094-ebec-3314-24b3aa54f927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc.,
Application
ANDA204975
Marketing category
ANDA
Marketing start
2022-06-10
Substance
FESOTERODINE FUMARATE
Active strength
8 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 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
43598-248-30Fesoterodine fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
43598-248-90Fesoterodine fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-248-30EA - Each43598-2480d277448-f526-44d6-a901-342412a7915712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-248FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES INC.,]9Current NDC, Legacy NDC, 2 package rows20250514_5c5d2a97-9029-744f-c410-a4bbbe9761a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN5c5d2a97-9029-744f-c410-a4bbbe9761a810
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN5c5d2a97-9029-744f-c410-a4bbbe9761a810
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD5c5d2a97-9029-744f-c410-a4bbbe9761a810
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD5c5d2a97-9029-744f-c410-a4bbbe9761a810
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY5c5d2a97-9029-744f-c410-a4bbbe9761a810
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY5c5d2a97-9029-744f-c410-a4bbbe9761a810
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
43598-248-304359802483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-30) 2022-06-100000-00-00NoNoCurrent
43598-248-904359802489090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-90) 2022-06-100000-00-00NoNoCurrent