Solifenacin Succinate

Product NDC
67184-0517
11-digit product format
671840517
Labeler code
67184
Product ID
67184-0517_4ad0176d-0102-457a-9fcb-472dcedd9709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA209333
Marketing category
ANDA
Marketing start
2020-04-01
Substance
SOLIFENACIN SUCCINATE
Active strength
10 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

Additional Listing Data#

Finished product
Yes
Brand name base
Solifenacin Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67184-0517-16718405170130 TABLET, FILM COATED in 1 BOTTLE (67184-0517-1) 2020-04-010000-00-00NoNoCurrent
67184-0517-26718405170290 TABLET, FILM COATED in 1 BOTTLE (67184-0517-2) 2020-04-010000-00-00NoNoCurrent
67184-0517-3671840517032000 TABLET, FILM COATED in 1 BOTTLE (67184-0517-3) 2020-04-010000-00-00NoNoCurrent
67184-0517-46718405170440 TABLET, FILM COATED in 1 BLISTER PACK (67184-0517-4) 2020-04-010000-00-00NoNoCurrent