FDA.reportPublic FDA data

FESOTERODINE FUMARATE

Product NDC
31722-034
11-digit product format
317220034
Labeler code
31722
Product ID
31722-034_2f836bf8-7034-db2e-e063-6394a90a3a3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FESOTERODINE FUMARATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204792
Marketing category
ANDA
Marketing start
2024-01-09
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
31722-034-30FESOTERODINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
31722-034-90FESOTERODINE FUMARATE90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-034-30EA - Each31722-034b7240314-b2a0-4452-bb50-0b8cdd66879012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-034FESOTERODINE FUMARATE (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250306_dc532c6c-ff0d-488a-8a92-b1b0f37c944e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNdc532c6c-ff0d-488a-8a92-b1b0f37c944e2
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNdc532c6c-ff0d-488a-8a92-b1b0f37c944e2
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDdc532c6c-ff0d-488a-8a92-b1b0f37c944e2
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDdc532c6c-ff0d-488a-8a92-b1b0f37c944e2
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYdc532c6c-ff0d-488a-8a92-b1b0f37c944e2
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYdc532c6c-ff0d-488a-8a92-b1b0f37c944e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-034-303172200343030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-30) 2024-01-09NoNoCurrent
31722-034-903172200349090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-90) 2024-01-09NoNoCurrent