solifenacin succinate

Generic: solifenacin succinate

Labeler: bostal llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler bostal llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-286
Product ID 35561-286_49fcc8a4-31aa-6975-e063-6394a90a9389
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210281
Listing Expiration 2027-12-31
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 35561286
Hyphenated Format 35561-286

Supplemental Identifiers

RxCUI
477367 477372
UPC
0335561286137 0335561285130
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 ANDA210281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 129032 TABLET, FILM COATED in 1 BOX (35561-286-00)
  • 30 TABLET, FILM COATED in 1 BOTTLE (35561-286-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (35561-286-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (35561-286-13)
source: ndc

Packages (4)

35561-286-00 129032 TABLET, FILM COATED in 1 BOX (35561-286-00) 35561-286-10 30 TABLET, FILM COATED in 1 BOTTLE (35561-286-10) 35561-286-11 90 TABLET, FILM COATED in 1 BOTTLE (35561-286-11) 35561-286-13 500 TABLET, FILM COATED in 1 BOTTLE (35561-286-13)

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": "49fcc8a4-31aa-6975-e063-6394a90a9389", "openfda": {"upc": ["0335561286137", "0335561285130"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["d155c739-6870-4938-ba91-8c1b4b90afe4"], "manufacturer_name": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "129032 TABLET, FILM COATED in 1 BOX (35561-286-00)", "package_ndc": "35561-286-00", "marketing_start_date": "20190520"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (35561-286-10)", "package_ndc": "35561-286-10", "marketing_start_date": "20190520"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (35561-286-11)", "package_ndc": "35561-286-11", "marketing_start_date": "20190520"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (35561-286-13)", "package_ndc": "35561-286-13", "marketing_start_date": "20190520"}], "brand_name": "Solifenacin Succinate", "product_id": "35561-286_49fcc8a4-31aa-6975-e063-6394a90a9389", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "35561-286", "generic_name": "solifenacin succinate", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA210281", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20271231"}