solifenacin succinate

Generic: solifenacin succinate

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

Drug Facts

Product Profile

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

solifenacin succinate 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-192
Product ID 46708-192_aea71cde-6d62-4f8d-b813-47064cb213d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205575
Listing Expiration 2026-12-31
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 46708192
Hyphenated Format 46708-192

Supplemental Identifiers

RxCUI
477367 477372
UPC
0346708193300
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 ANDA205575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 80 TABLET, COATED in 1 CARTON (46708-192-08)
  • 30 TABLET, COATED in 1 BOTTLE (46708-192-30)
  • 90 TABLET, COATED in 1 BOTTLE (46708-192-90)
  • 1000 TABLET, COATED in 1 BOTTLE (46708-192-91)
source: ndc

Packages (4)

46708-192-08 80 TABLET, COATED in 1 CARTON (46708-192-08) 46708-192-30 30 TABLET, COATED in 1 BOTTLE (46708-192-30) 46708-192-90 90 TABLET, COATED in 1 BOTTLE (46708-192-90) 46708-192-91 1000 TABLET, COATED in 1 BOTTLE (46708-192-91)

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": "aea71cde-6d62-4f8d-b813-47064cb213d9", "openfda": {"upc": ["0346708193300"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["aea71cde-6d62-4f8d-b813-47064cb213d9"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "80 TABLET, COATED in 1 CARTON (46708-192-08)", "package_ndc": "46708-192-08", "marketing_start_date": "20190520"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (46708-192-30)", "package_ndc": "46708-192-30", "marketing_start_date": "20190520"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (46708-192-90)", "package_ndc": "46708-192-90", "marketing_start_date": "20190520"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (46708-192-91)", "package_ndc": "46708-192-91", "marketing_start_date": "20190520"}], "brand_name": "Solifenacin Succinate", "product_id": "46708-192_aea71cde-6d62-4f8d-b813-47064cb213d9", "dosage_form": "TABLET, COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "46708-192", "generic_name": "Solifenacin Succinate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Solifenacin Succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "5 mg/1"}], "application_number": "ANDA205575", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20261231"}