Fesoterodine Fumarate Tablet, Film Coated, Extended Release
FDA Label NDC 70771-1168

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Fesoterodine Fumarate (NDC 70771-1168). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1168-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 4 mg

Rx only

90 tablets

Fesoterodine Er Tablets, 4 mg (9b26e45d Eef8 463b 9773 9ce326ecb333 06)

Fesoterodine Er Tablets, 4 mg (9b26e45d Eef8 463b 9773 9ce326ecb333 06)

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

Fesoterodine Er Tablets, 8 mg (9b26e45d Eef8 463b 9773 9ce326ecb333 07)

Fesoterodine Er Tablets, 8 mg (9b26e45d Eef8 463b 9773 9ce326ecb333 07)

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