trospium chloride

Generic: trospium chloride

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

Drug Facts

Product Profile

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

trospium chloride 20 mg/1

Manufacturer
CIPLA USA INC.,

Identifiers & Regulatory

Product NDC 69097-912
Product ID 69097-912_9058b0be-0e24-418e-9be7-597c00fe8b70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091688
Listing Expiration 2026-12-31
Marketing Start 2016-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097912
Hyphenated Format 69097-912

Supplemental Identifiers

RxCUI
857560
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 ANDA091688 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02)
  • 60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15)
source: ndc

Packages (3)

Ingredients (1)

trospium chloride (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "9058b0be-0e24-418e-9be7-597c00fe8b70", "openfda": {"unii": ["1E6682427E"], "rxcui": ["857560"], "spl_set_id": ["6a711666-9e80-4728-b745-e7dc86f57510"], "manufacturer_name": ["CIPLA USA INC.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02)", "package_ndc": "69097-912-02", "marketing_start_date": "20160923"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)", "package_ndc": "69097-912-03", "marketing_start_date": "20160923"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15)", "package_ndc": "69097-912-15", "marketing_start_date": "20160923"}], "brand_name": "Trospium Chloride", "product_id": "69097-912_9058b0be-0e24-418e-9be7-597c00fe8b70", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "69097-912", "generic_name": "Trospium Chloride", "labeler_name": "CIPLA USA INC.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trospium Chloride", "active_ingredients": [{"name": "TROSPIUM CHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA091688", "marketing_category": "ANDA", "marketing_start_date": "20160923", "listing_expiration_date": "20261231"}