FDA.reportPublic FDA data

Fesoterodine Fumarate

Product NDC
46708-175
11-digit product format
467080175
Labeler code
46708
Product ID
46708-175_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
4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
A204973-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04
A204973-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204973-001AB
A204973-002AB

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 22:54:322026-06A204973-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04a50c72e98297…
2026-08-01 22:54:322026-06A204973-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2023-01-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204973-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204973-002AB1a50c72e98297…

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 FUMARATEAlembic Pharmaceuticals Inc.299db62d-9658-4796-b449-657fa859c5cd2025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204973
application number: ANDA204973
Fesoterodine FumarateFESOTERODINE FUMARATEAlembic Pharmaceuticals Limited571147f2-e182-44b5-9d0b-ecfc3265cc2d2023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204973
application number: ANDA204973
ndc (product): 46708-175

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 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
571147f2-e182-44b5-9d0b-ecfc3265cc2dAvailable on FDA.report

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
46708-175-10Fesoterodine Fumarate100 in 1 CARTONTABLET, EXTENDED RELEASE1001
46708-175-30Fesoterodine Fumarate30 in 1 BOTTLETABLET, EXTENDED RELEASE301
46708-175-90Fesoterodine Fumarate90 in 1 BOTTLETABLET, EXTENDED RELEASE901
46708-175-91Fesoterodine Fumarate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-175FESOTERODINE 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
46708-175-1046708017510100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-175-10) 2023-01-06NoNoCurrent
46708-175-304670801753030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-30) 2023-01-06NoNoCurrent
46708-175-904670801759090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-90) 2023-01-06NoNoCurrent
46708-175-91467080175911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-91) 2023-01-06NoNoCurrent