FDA.reportPublic FDA data

fesoterodine fumarate

Product NDC
68382-480
11-digit product format
683820480
Labeler code
68382
Product ID
68382-480_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fesoterodine fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA204946
Marketing category
ANDA
Marketing start
2017-12-07
Substance
FESOTERODINE FUMARATE
Active strength
8 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
ndc (product): 68382-480
fesoterodine fumarateFESOTERODINE FUMARATEZydus Lifesciences Limited26e8cc63-1e1d-4a77-8f53-4c38bcf0d4432024-11-30Exact identifier
application applno (ANDA): 204946
application number: ANDA204946

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 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
8c68e918-b47b-466d-80bc-4f521aa74607Available 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
68382-480-06fesoterodine fumarate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307
68382-480-16fesoterodine fumarate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE907
68382-480-30fesoterodine fumarate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107
68382-480-77fesoterodine fumarate10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-480-06EA - Each68382-4802fd9b4c8-e52a-45d4-952f-e935aab6102712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-480FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 4 package rows20250104_8c68e918-b47b-466d-80bc-4f521aa74607.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN8c68e918-b47b-466d-80bc-4f521aa746077
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN8c68e918-b47b-466d-80bc-4f521aa746077
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD8c68e918-b47b-466d-80bc-4f521aa746077
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD8c68e918-b47b-466d-80bc-4f521aa746077
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY8c68e918-b47b-466d-80bc-4f521aa746077
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY8c68e918-b47b-466d-80bc-4f521aa746077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-480-066838204800630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-06) 2017-12-070000-00-00NoNoCurrent
68382-480-166838204801690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-16) 2017-12-070000-00-00NoNoCurrent
68382-480-306838204803010 in 1 BLISTER PACKHistorical
68382-480-776838204807710 BLISTER PACK in 1 CARTON (68382-480-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-480-30) 10 blister pack2017-12-070000-00-00NoNoCurrent