FDA.reportPublic FDA data

FESOTERODINE FUMARATE

Product NDC
65862-767
11-digit product format
658620767
Labeler code
65862
Product ID
65862-767_33d91059-f2d5-482f-a47f-b1dccb7c5b22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FESOTERODINE FUMARATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205007
Marketing category
ANDA
Marketing start
2022-06-17
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
A205007-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-02-17
A205007-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205007-001AB
A205007-002AB

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 22:54:322026-06A205007-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-02-17a50c72e98297…
2026-08-01 22:54:322026-06A205007-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205007-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205007-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FESOTERODINE FUMARATEFESOTERODINE FUMARATEAurobindo Pharma Limiteddc8f6158-3c2b-4ec0-a951-e04468b83bb12024-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205007
application number: ANDA205007
ndc (product): 65862-767

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
dc8f6158-3c2b-4ec0-a951-e04468b83bb1Available 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
65862-767-30FESOTERODINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-767-30EA - Each65862-767aa455e7d-2026-4f16-b40b-13114fa2517b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-767FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]5Current NDC, Legacy NDC, 1 package rows20241222_dc8f6158-3c2b-4ec0-a951-e04468b83bb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNdc8f6158-3c2b-4ec0-a951-e04468b83bb15
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNdc8f6158-3c2b-4ec0-a951-e04468b83bb15
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDdc8f6158-3c2b-4ec0-a951-e04468b83bb15
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDdc8f6158-3c2b-4ec0-a951-e04468b83bb15
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYdc8f6158-3c2b-4ec0-a951-e04468b83bb15
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYdc8f6158-3c2b-4ec0-a951-e04468b83bb15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-767-306586207673030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-767-30) 2022-06-170000-00-00NoNoCurrent