FDA.reportPublic FDA data

Fesoterodine Fumarate

Product NDC
46708-176
11-digit product format
467080176
Labeler code
46708
Product ID
46708-176_571147f2-e182-44b5-9d0b-ecfc3265cc2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204973
Marketing category
ANDA
Marketing start
2023-01-06
Substance
FESOTERODINE FUMARATE
Active strength
8 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 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
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
46708-176-10Fesoterodine Fumarate100 in 1 CARTONTABLET, EXTENDED RELEASE1001
46708-176-30Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE301
46708-176-90Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE901
46708-176-91Fesoterodine Fumarate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-176FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20230202_571147f2-e182-44b5-9d0b-ecfc3265cc2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN571147f2-e182-44b5-9d0b-ecfc3265cc2d1
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN571147f2-e182-44b5-9d0b-ecfc3265cc2d1
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD571147f2-e182-44b5-9d0b-ecfc3265cc2d1
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD571147f2-e182-44b5-9d0b-ecfc3265cc2d1
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY571147f2-e182-44b5-9d0b-ecfc3265cc2d1
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY571147f2-e182-44b5-9d0b-ecfc3265cc2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-176-1046708017610100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10) 2023-01-06NoNoCurrent
46708-176-304670801763030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-30) 2023-01-06NoNoCurrent
46708-176-904670801769090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-90) 2023-01-06NoNoCurrent
46708-176-91467080176911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-91) 2023-01-06NoNoCurrent