solifenacin succinate

Generic: solifenacin succinate

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name solifenacin succinate
Generic Name solifenacin succinate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

solifenacin succinate 10 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-387
Product ID 68462-387_85807e7f-3f25-4df8-812e-fa6b281d559b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209239
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 68462387
Hyphenated Format 68462-387

Supplemental Identifiers

RxCUI
477367 477372
UPC
0368462386309
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 ANDA209239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90)
source: ndc

Packages (3)

68462-387-14 10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 68462-387-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30) 68462-387-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90)

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": "85807e7f-3f25-4df8-812e-fa6b281d559b", "openfda": {"upc": ["0368462386309"], "unii": ["KKA5DLD701"], "rxcui": ["477367", "477372"], "spl_set_id": ["010c0657-c907-477f-8bd7-5d455a5f50eb"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-387-14)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68462-387-14", "marketing_start_date": "20190520"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30)", "package_ndc": "68462-387-30", "marketing_start_date": "20190520"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90)", "package_ndc": "68462-387-90", "marketing_start_date": "20190520"}], "brand_name": "solifenacin succinate", "product_id": "68462-387_85807e7f-3f25-4df8-812e-fa6b281d559b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68462-387", "generic_name": "solifenacin succinate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "solifenacin succinate", "active_ingredients": [{"name": "SOLIFENACIN SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA209239", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20271231"}