solifenacin succinate

Generic: solifenacin succinate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-149
Product ID 33342-149_fbd6e753-1ed2-418a-8667-c674b215eabb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204374
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342149
Hyphenated Format 33342-149

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 ANDA204374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 CONTAINER (33342-149-07)
  • 90 TABLET, COATED in 1 CONTAINER (33342-149-10)
source: ndc

Packages (2)

33342-149-07 30 TABLET, COATED in 1 CONTAINER (33342-149-07) 33342-149-10 90 TABLET, COATED in 1 CONTAINER (33342-149-10)

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": "fbd6e753-1ed2-418a-8667-c674b215eabb", "openfda": {"unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["fbd6e753-1ed2-418a-8667-c674b215eabb"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 CONTAINER (33342-149-07)", "package_ndc": "33342-149-07", "marketing_start_date": "20240220"}, {"sample": false, "description": "90 TABLET, COATED in 1 CONTAINER (33342-149-10)", "package_ndc": "33342-149-10", "marketing_start_date": "20240220"}], "brand_name": "solifenacin succinate", "product_id": "33342-149_fbd6e753-1ed2-418a-8667-c674b215eabb", "dosage_form": "TABLET, COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "33342-149", "generic_name": "solifenacin succinate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "solifenacin succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA204374", "marketing_category": "ANDA", "marketing_start_date": "20240220", "listing_expiration_date": "20261231"}