FDA.reportPublic FDA data

fesoterodine fumarate

Product NDC
70771-1168
11-digit product format
707711168
Labeler code
70771
Product ID
70771-1168_5b9a792a-f173-43f9-917a-af99185196e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fesoterodine fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA204946
Marketing category
ANDA
Marketing start
2017-12-07
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
A204946-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03
A204946-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204946-001AB
A204946-002AB

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 22:54:322026-06A204946-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03a50c72e98297…
2026-08-01 22:54:322026-06A204946-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204946-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204946-002AB1a50c72e98297…

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 FUMARATEZydus Pharmaceuticals USA Inc.8c68e918-b47b-466d-80bc-4f521aa746072025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204946
application number: ANDA204946
fesoterodine fumarateFESOTERODINE FUMARATEZydus Lifesciences Limited26e8cc63-1e1d-4a77-8f53-4c38bcf0d4432024-11-30Exact identifier
application applno (ANDA): 204946
application number: ANDA204946
ndc (product): 70771-1168

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
26e8cc63-1e1d-4a77-8f53-4c38bcf0d443Available 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
70771-1168-2fesoterodine fumarate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE105
70771-1168-3fesoterodine fumarate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
70771-1168-4fesoterodine fumarate10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE105
70771-1168-9fesoterodine fumarate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1168FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 4 package rows20241201_26e8cc63-1e1d-4a77-8f53-4c38bcf0d443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY26e8cc63-1e1d-4a77-8f53-4c38bcf0d4435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1168-27077111680210 in 1 BLISTER PACKHistorical
70771-1168-37077111680330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-3) 2017-12-070000-00-00NoNoCurrent
70771-1168-47077111680410 BLISTER PACK in 1 CARTON (70771-1168-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1168-2) 10 blister pack2017-12-070000-00-00NoNoCurrent
70771-1168-97077111680990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-9) 2017-12-070000-00-00NoNoCurrent