solifenacin succinate

Generic: solifenacin succinate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 5 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3795
Product ID 0591-3795_4a8ad4ea-e579-4269-b16d-fdc627ba1114
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202551
Listing Expiration 2026-12-31
Marketing Start 2020-06-30

Pharmacologic Class

Classes
cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913795
Hyphenated Format 0591-3795

Supplemental Identifiers

RxCUI
477367 477372
UPC
0305913796300 0305913795303
UNII
KKA5DLD701

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name solifenacin succinate (source: ndc)
Generic Name solifenacin succinate (source: ndc)
Application Number ANDA202551 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0591-3795-19)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0591-3795-30)
source: ndc

Packages (2)

0591-3795-19 90 TABLET, FILM COATED in 1 BOTTLE (0591-3795-19) 0591-3795-30 30 TABLET, FILM COATED in 1 BOTTLE (0591-3795-30)

Ingredients (1)

solifenacin succinate (5 mg/1)

Linked Drug Pages (1)

Solifenacin succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a8ad4ea-e579-4269-b16d-fdc627ba1114", "openfda": {"upc": ["0305913796300", "0305913795303"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["02e2aa54-1ed8-445a-a082-ac2c64b339fe"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0591-3795-19)", "package_ndc": "0591-3795-19", "marketing_start_date": "20200630"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0591-3795-30)", "package_ndc": "0591-3795-30", "marketing_start_date": "20230123"}], "brand_name": "Solifenacin succinate", "product_id": "0591-3795_4a8ad4ea-e579-4269-b16d-fdc627ba1114", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0591-3795", "generic_name": "solifenacin succinate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "5 mg/1"}], "application_number": "ANDA202551", "marketing_category": "ANDA", "marketing_start_date": "20200630", "listing_expiration_date": "20261231"}