solifenacin succinate

Generic: solifenacin succinate

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

solifenacin succinate 5 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-427
Product ID 50228-427_b9432117-2521-7360-e053-2a95a90acd2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211657
Listing Expiration 2026-12-31
Marketing Start 2019-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228427
Hyphenated Format 50228-427

Supplemental Identifiers

RxCUI
477367 477372
UPC
0350228428903 0350228428057 0350228428309 0350228427050 0350228427906 0350228427302
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 ANDA211657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (50228-427-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-427-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50228-427-90)
source: ndc

Packages (3)

50228-427-05 500 TABLET, FILM COATED in 1 BOTTLE (50228-427-05) 50228-427-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-427-30) 50228-427-90 90 TABLET, FILM COATED in 1 BOTTLE (50228-427-90)

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": "b9432117-2521-7360-e053-2a95a90acd2a", "openfda": {"upc": ["0350228428903", "0350228428057", "0350228428309", "0350228427050", "0350228427906", "0350228427302"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["a6f154d9-7463-4b80-b80e-c06a06e36141"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (50228-427-05)", "package_ndc": "50228-427-05", "marketing_start_date": "20190520"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-427-30)", "package_ndc": "50228-427-30", "marketing_start_date": "20190520"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50228-427-90)", "package_ndc": "50228-427-90", "marketing_start_date": "20190520"}], "brand_name": "SOLIFENACIN SUCCINATE", "product_id": "50228-427_b9432117-2521-7360-e053-2a95a90acd2a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "50228-427", "generic_name": "SOLIFENACIN SUCCINATE", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOLIFENACIN SUCCINATE", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "5 mg/1"}], "application_number": "ANDA211657", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20261231"}