Fesoterodine Fumarate

Product NDC
62332-175
11-digit product format
623320175
Labeler code
62332
Product ID
62332-175_2fc9ba3f-2336-45b8-9020-bffc1298a6e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fesoterodine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204973
Marketing category
ANDA
Marketing start
2023-01-06
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
62332-175-10Fesoterodine Fumarate100 in 1 CARTONTABLET, EXTENDED RELEASE1008
62332-175-30Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE308
62332-175-90Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE908
62332-175-91Fesoterodine Fumarate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-175-30EA - Each62332-1757916e05e-bb70-482d-a445-1b6307194dd112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-175FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20240810_299db62d-9658-4796-b449-657fa859c5cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN299db62d-9658-4796-b449-657fa859c5cd8
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN299db62d-9658-4796-b449-657fa859c5cd8
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD299db62d-9658-4796-b449-657fa859c5cd8
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD299db62d-9658-4796-b449-657fa859c5cd8
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY299db62d-9658-4796-b449-657fa859c5cd8
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY299db62d-9658-4796-b449-657fa859c5cd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-175-1062332017510100 TABLET, EXTENDED RELEASE in 1 CARTON (62332-175-10) 2023-01-060000-00-00NoNoCurrent
62332-175-306233201753030 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-175-30) 2023-01-060000-00-00NoNoCurrent
62332-175-906233201759090 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-175-90) 2023-01-060000-00-00NoNoCurrent
62332-175-91623320175911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-175-91) 2023-01-060000-00-00NoNoCurrent