Solifenacin

Product NDC
68382-988
11-digit product format
683820988
Labeler code
68382
Product ID
68382-988_a91df415-ca99-476a-b7b7-11e5d2c169db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207721
Marketing category
ANDA
Marketing start
2022-02-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-988-066838209880630 TABLET, FILM COATED in 1 BOTTLE (68382-988-06) 2022-02-100000-00-00NoNoCurrent
68382-988-166838209881690 TABLET, FILM COATED in 1 BOTTLE (68382-988-16) 2022-02-100000-00-00NoNoCurrent