NDC 68382-480

fesoterodine fumarate

Fesoterodine Fumarate

fesoterodine fumarate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Fesoterodine Fumarate.

Product ID68382-480_83c43462-1843-41ed-b0d7-ea91563513c0
NDC68382-480
Product TypeHuman Prescription Drug
Proprietary Namefesoterodine fumarate
Generic NameFesoterodine Fumarate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-12-07
Marketing CategoryANDA / ANDA
Application NumberANDA204946
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameFESOTERODINE FUMARATE
Active Ingredient Strength8 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-480-06

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-06)
Marketing Start Date2017-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-480-06 [68382048006]

fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-07

NDC 68382-480-16 [68382048016]

fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-07

NDC 68382-480-77 [68382048077]

fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-07

NDC 68382-480-30 [68382048030]

fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-07

Drug Details

Active Ingredients

IngredientStrength
FESOTERODINE FUMARATE8 mg/1

NDC Crossover Matching brand name "fesoterodine fumarate" or generic name "Fesoterodine Fumarate"

NDCBrand NameGeneric Name
43598-247Fesoterodine fumarateFesoterodine fumarate
43598-248Fesoterodine fumarateFesoterodine fumarate
51407-661Fesoterodine fumarateFesoterodine fumarate
51407-662Fesoterodine fumarateFesoterodine fumarate
62332-175Fesoterodine FumarateFesoterodine Fumarate
62332-176Fesoterodine FumarateFesoterodine Fumarate
62559-376Fesoterodine FumarateFesoterodine Fumarate
65162-369Fesoterodine FumarateFesoterodine Fumarate
65162-370Fesoterodine FumarateFesoterodine Fumarate
65862-766FESOTERODINE FUMARATEFESOTERODINE FUMARATE
68382-479fesoterodine fumaratefesoterodine fumarate
68382-480fesoterodine fumaratefesoterodine fumarate
70771-1168fesoterodine fumaratefesoterodine fumarate
70771-1169fesoterodine fumaratefesoterodine fumarate
0069-0242Toviazfesoterodine fumarate
0069-0244Toviazfesoterodine fumarate
55154-2737Toviazfesoterodine fumarate
55154-2738Toviazfesoterodine fumarate
63539-183Toviazfesoterodine fumarate
63539-242Toviazfesoterodine fumarate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.