trospium chloride

Generic: trospium chloride

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

Drug Facts

Product Profile

Brand Name trospium chloride
Generic Name trospium chloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

trospium chloride 20 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-461
Product ID 68462-461_44d944da-d624-4016-a3eb-ce810b62fb17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091575
Listing Expiration 2026-12-31
Marketing Start 2010-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462461
Hyphenated Format 68462-461

Supplemental Identifiers

RxCUI
857560
UPC
0368462461600
UNII
1E6682427E

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 trospium chloride (source: ndc)
Generic Name trospium chloride (source: ndc)
Application Number ANDA091575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60)
source: ndc

Packages (4)

68462-461-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05) 68462-461-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) 68462-461-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30) 68462-461-60 60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60)

Ingredients (1)

trospium chloride (20 mg/1)

Linked Drug Pages (1)

Trospium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44d944da-d624-4016-a3eb-ce810b62fb17", "openfda": {"upc": ["0368462461600"], "unii": ["1E6682427E"], "rxcui": ["857560"], "spl_set_id": ["d5c837a4-d1c6-4615-b7ad-27f3162a03aa"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05)", "package_ndc": "68462-461-05", "marketing_start_date": "20100813"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10)", "package_ndc": "68462-461-10", "marketing_start_date": "20230630"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30)", "package_ndc": "68462-461-30", "marketing_start_date": "20100813"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60)", "package_ndc": "68462-461-60", "marketing_start_date": "20100813"}], "brand_name": "Trospium Chloride", "product_id": "68462-461_44d944da-d624-4016-a3eb-ce810b62fb17", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68462-461", "generic_name": "Trospium Chloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trospium Chloride", "active_ingredients": [{"name": "TROSPIUM CHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA091575", "marketing_category": "ANDA", "marketing_start_date": "20100813", "listing_expiration_date": "20261231"}