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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204975-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13
A204975-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204975-001AB
A204975-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204975-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13a50c72e98297…
2026-08-01 22:54:322026-06A204975-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204975-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204975-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fesoterodine fumarateFESOTERODINE FUMARATEGolden State Medical Supply, Inc.e5e6e146-d39a-471c-e053-2995a90a75382025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204975
application number: ANDA204975
Fesoterodine fumarateFESOTERODINE FUMARATEDr.Reddy's Laboratories Inc.,5c5d2a97-9029-744f-c410-a4bbbe9761a82025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204975
application number: ANDA204975
ndc (product): 43598-248

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EOS72165S7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
810071Internal RxNorm lookup
810077Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c5d2a97-9029-744f-c410-a4bbbe9761a8Available on FDA.report

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