solifenacin succinate

Generic: solifenacin succinate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-879
Product ID 65862-879_ececaabb-2b01-4ef5-b5e8-a927478deccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206817
Listing Expiration 2026-12-31
Marketing Start 2022-12-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862879
Hyphenated Format 65862-879

Supplemental Identifiers

RxCUI
477367 477372
UPC
0365862879301 0365862878304
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 ANDA206817 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-879-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-879-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-879-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-879-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-879-99)
source: ndc

Packages (4)

65862-879-03 3 BLISTER PACK in 1 CARTON (65862-879-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-879-10) 65862-879-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-879-30) 65862-879-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-879-90) 65862-879-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-879-99)

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": "ececaabb-2b01-4ef5-b5e8-a927478deccc", "openfda": {"upc": ["0365862879301", "0365862878304"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["92b37f2d-b1cf-49e6-a13b-0ead92c0604c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-879-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-879-10)", "package_ndc": "65862-879-03", "marketing_start_date": "20221227"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-879-30)", "package_ndc": "65862-879-30", "marketing_start_date": "20221227"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-879-90)", "package_ndc": "65862-879-90", "marketing_start_date": "20221227"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-879-99)", "package_ndc": "65862-879-99", "marketing_start_date": "20221227"}], "brand_name": "Solifenacin Succinate", "product_id": "65862-879_ececaabb-2b01-4ef5-b5e8-a927478deccc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "65862-879", "generic_name": "Solifenacin Succinate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA206817", "marketing_category": "ANDA", "marketing_start_date": "20221227", "listing_expiration_date": "20261231"}