fesoterodine fumarate extended-release tablets

SPL v5

SPL

SPL Set ID 26e8cc63-1e1d-4a77-8f53-4c38bcf0d443

Route

oral

Published

Effective Date 2022-10-10

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fesoterodine (4 mg)

Inactive Ingredients

starch, corn hypromelloses lactose monohydrate lecithin, soybean magnesium stearate cellulose, microcrystalline povidone talc titanium dioxide xanthan gum ferric oxide yellow polyvinyl alcohol, unspecified

Identifiers & Packaging

Pill Appearance

Imprint: 480 Shape: oval Color: yellow Color: white Size: 13 mm Score: 1

Marketing Status

anda active Since 2017-12-07

Description

NDC 70771-1168-9 in bottle of 90 tablets Fesoterodine Fumarate Extended-release Tablets, 4 mg Rx only 90 tablets NDC 70771-1169-9 in bottle of 90 tablets Fesoterodine Fumarate Extended-release Tablets, 8 mg Rx only 90 tablets

Medication Information

Description

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

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

Structured Label Content

Package Label.principal Display Panel (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

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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 NDC 70771-1169-9 in bottle of 90 tablets Fesoterodine Fumarate Extended-release Tablets, 8 mg Rx only 90 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:58.929899 · Updated: 2026-03-14T22:18:18.443233