solifenacin succinate

Generic: solifenacin succinate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-328
Product ID 29300-328_82c150d9-febf-4425-bf85-0e4586ae1741
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211701
Listing Expiration 2026-12-31
Marketing Start 2020-03-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300328
Hyphenated Format 29300-328

Supplemental Identifiers

RxCUI
477367 477372
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 ANDA211701 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (29300-328-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (29300-328-13)
  • 90 TABLET, FILM COATED in 1 BOTTLE (29300-328-19)
source: ndc

Packages (3)

29300-328-05 500 TABLET, FILM COATED in 1 BOTTLE (29300-328-05) 29300-328-13 30 TABLET, FILM COATED in 1 BOTTLE (29300-328-13) 29300-328-19 90 TABLET, FILM COATED in 1 BOTTLE (29300-328-19)

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": "82c150d9-febf-4425-bf85-0e4586ae1741", "openfda": {"unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["51ff19b4-09ac-4796-8869-671ddd62c578"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (29300-328-05)", "package_ndc": "29300-328-05", "marketing_start_date": "20200323"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (29300-328-13)", "package_ndc": "29300-328-13", "marketing_start_date": "20200323"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (29300-328-19)", "package_ndc": "29300-328-19", "marketing_start_date": "20200323"}], "brand_name": "Solifenacin Succinate", "product_id": "29300-328_82c150d9-febf-4425-bf85-0e4586ae1741", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "29300-328", "generic_name": "Solifenacin Succinate", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "5 mg/1"}], "application_number": "ANDA211701", "marketing_category": "ANDA", "marketing_start_date": "20200323", "listing_expiration_date": "20261231"}