Solifenacin Succinate

Product NDC
60505-4702
11-digit product format
605054702
Labeler code
60505
Product ID
60505-4702_70d28c29-7862-4ead-a53f-d3646aba26dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA209333
Marketing category
ANDA
Marketing start
2019-05-20
Marketing end
2027-11-30
Substance
SOLIFENACIN SUCCINATE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solifenacin Succinate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKKA5DLD701
Rxcui477367, 477372

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4702-3Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4702-3EA - Each60505-470230e2d3aa-283e-4fc1-94ef-80dceb22bdb012019-06-19
60505-4702-9EA - Each60505-4702d86375d9-3e08-4d59-a4d3-ad8a513d9e5b12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4702SOLIFENACIN SUCCINATE TABLET, FILM COATED [APOTEX CORP.]6Current NDC, Legacy NDC, 1 package rows20230211_1d96b386-febf-a510-a896-033e832c8f30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN1d96b386-febf-a510-a896-033e832c8f307
477367solifenacin succinate 5 MG Oral TabletPSN1d96b386-febf-a510-a896-033e832c8f307
477372solifenacin succinate 10 MG Oral TabletSCD1d96b386-febf-a510-a896-033e832c8f307
477367solifenacin succinate 5 MG Oral TabletSCD1d96b386-febf-a510-a896-033e832c8f307
477367solifenacin succinate 5 MG Oral TabletPSNd6525817-bea1-4a4c-bed4-4873ee202cc81
477367solifenacin succinate 5 MG Oral TabletSCDd6525817-bea1-4a4c-bed4-4873ee202cc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4702-36050547020330 TABLET, FILM COATED in 1 BOTTLE (60505-4702-3) 2019-05-202027-11-30NoNoCurrent
60505-4702-96050547020990 TABLET, FILM COATED in 1 BOTTLE (60505-4702-9) 2019-05-202022-02-28NoNoCurrent