solifenacin succinate

Generic: solifenacin succinate

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler ajanta pharma usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-038
Product ID 27241-038_abee70a8-6884-4748-b266-11a84236c0a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205483
Listing Expiration 2027-12-31
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 27241038
Hyphenated Format 27241-038

Supplemental Identifiers

RxCUI
477367 477372
UPC
0327241038037 0327241037092 0327241038099 0327241037030
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 ANDA205483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (27241-038-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (27241-038-09)
source: ndc

Packages (2)

27241-038-03 30 TABLET, FILM COATED in 1 BOTTLE (27241-038-03) 27241-038-09 90 TABLET, FILM COATED in 1 BOTTLE (27241-038-09)

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": "abee70a8-6884-4748-b266-11a84236c0a1", "openfda": {"upc": ["0327241038037", "0327241037092", "0327241038099", "0327241037030"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["9558ed7a-e942-4261-8aea-6033352f79b8"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (27241-038-03)", "package_ndc": "27241-038-03", "marketing_start_date": "20190520"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (27241-038-09)", "package_ndc": "27241-038-09", "marketing_start_date": "20190520"}], "brand_name": "solifenacin succinate", "product_id": "27241-038_abee70a8-6884-4748-b266-11a84236c0a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "27241-038", "generic_name": "solifenacin succinate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "solifenacin succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA205483", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20271231"}