solifenacin succinate

Generic: solifenacin succinate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

solifenacin succinate 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-528
Product ID 67877-528_e0e2cc86-60c8-450a-86f8-c551308ff027
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210224
Listing Expiration 2026-12-31
Marketing Start 2019-05-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877528
Hyphenated Format 67877-528

Supplemental Identifiers

RxCUI
477367 477372
UPC
0367877527307 0367877528908
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 ANDA210224 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-528-30)
  • 10 BLISTER PACK in 1 CARTON (67877-528-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-528-33)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-528-90)
source: ndc

Packages (3)

67877-528-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-528-30) 67877-528-38 10 BLISTER PACK in 1 CARTON (67877-528-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-528-33) 67877-528-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-528-90)

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": "e0e2cc86-60c8-450a-86f8-c551308ff027", "openfda": {"upc": ["0367877527307", "0367877528908"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["97d8a21e-4618-460f-8cf5-97a9d946039e"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-528-30)", "package_ndc": "67877-528-30", "marketing_start_date": "20190521"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-528-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-528-33)", "package_ndc": "67877-528-38", "marketing_start_date": "20190521"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-528-90)", "package_ndc": "67877-528-90", "marketing_start_date": "20190521"}], "brand_name": "Solifenacin Succinate", "product_id": "67877-528_e0e2cc86-60c8-450a-86f8-c551308ff027", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "67877-528", "generic_name": "Solifenacin Succinate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA210224", "marketing_category": "ANDA", "marketing_start_date": "20190521", "listing_expiration_date": "20261231"}