solifenacin succinate

Generic: solifenacin succinate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4703
Product ID 60505-4703_70d28c29-7862-4ead-a53f-d3646aba26dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209333
Marketing Start 2019-05-20
Marketing End 2027-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054703
Hyphenated Format 60505-4703

Supplemental Identifiers

RxCUI
477367 477372
UPC
0360505470235 0360505470334
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 ANDA209333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-4703-3)
source: ndc

Packages (1)

60505-4703-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4703-3)

Ingredients (1)

solifenacin succinate (10 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": "70d28c29-7862-4ead-a53f-d3646aba26dd", "openfda": {"upc": ["0360505470235", "0360505470334"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["1d96b386-febf-a510-a896-033e832c8f30"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-4703-3)", "package_ndc": "60505-4703-3", "marketing_end_date": "20271130", "marketing_start_date": "20190520"}], "brand_name": "Solifenacin Succinate", "product_id": "60505-4703_70d28c29-7862-4ead-a53f-d3646aba26dd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "60505-4703", "generic_name": "Solifenacin Succinate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA209333", "marketing_category": "ANDA", "marketing_end_date": "20271130", "marketing_start_date": "20190520"}