solifenacin succinate

Product NDC
33342-148
11-digit product format
333420148
Labeler code
33342
Product ID
33342-148_fbd6e753-1ed2-418a-8667-c674b215eabb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204374
Marketing category
ANDA
Marketing start
2024-02-20
Substance
SOLIFENACIN SUCCINATE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
KKA5DLD701SOLIFENACIN SUCCINATE242478-38-2SOLIFENACIN SUCCINATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-148-073334201480730 TABLET, COATED in 1 CONTAINER (33342-148-07) 2024-02-20NoNoHistorical
33342-148-103334201481090 TABLET, COATED in 1 CONTAINER (33342-148-10) 2024-02-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
solifenacin succinateMacleods Pharmaceuticals Limited2024-03-06Human Prescription Drug Label1