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Fesoterodine fumarate - Medication Information

Product NDC Code 70771-1168
Drug Name

Fesoterodine fumarate

Type Generic
Active Ingredients
Fesoterodine fumarate 4 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
RxCUI drug identifier 810071,
810077
Application Number ANDA204946
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1168-3 30 tablet, film coated, extended release in 1 bottle (70771-1168-3)
70771-1168-4 10 blister pack in 1 carton (70771-1168-4) / 10 tablet, film coated, extended release in 1 blister pack (70771-1168-2)
70771-1168-9 90 tablet, film coated, extended release in 1 bottle (70771-1168-9)
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Spl product data elements

Usually a list of ingredients in a drug product.
fesoterodine fumarate fesoterodine fumarate FESOTERODINE FUMARATE FESOTERODINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC TITANIUM DIOXIDE XANTHAN GUM FERRIC OXIDE YELLOW POLYVINYL ALCOHOL, UNSPECIFIED Light Yellow Oval 479 fesoterodine fumarate fesoterodine fumarate FESOTERODINE FUMARATE FESOTERODINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC TITANIUM DIOXIDE XANTHAN GUM POLYVINYL ALCOHOL, UNSPECIFIED White to Off-White Oval 480

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 Fesoterodine ER Tablets, 4 mg Fesoterodine ER Tablets, 8 mg

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API