SOLIFENACINE SUCCINATE

Product NDC
69097-261
11-digit product format
690970261
Labeler code
69097
Product ID
69097-261_13de71d6-5be1-49ee-b2cf-e3d7c8fd7b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA209839
Marketing category
ANDA
Marketing start
2019-05-20
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-261-02EA - Each69097-261d1a2b772-a754-4142-bf78-7433881f9c7312019-06-19
69097-261-05EA - Each69097-261e260a067-4c60-45fb-b7a0-a89aaa6ec25412019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-261SOLIFENACINE SUCCINATE TABLET [CIPLA USA INC.]3Legacy NDC20221208_74d4f207-2a8c-47e6-81f4-1b52f5e35b99.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-261-026909702610230 TABLET in 1 BOTTLE (69097-261-02) 30 tablet2019-05-200000-00-00NoNoCurrent
69097-261-056909702610590 TABLET in 1 BOTTLE (69097-261-05) 90 tablet2019-05-200000-00-00NoNoCurrent
69097-261-15690970261151000 TABLET in 1 BOTTLE (69097-261-15) 1000 tablet2019-05-200000-00-00NoNoCurrent