trospium chloride

Generic: trospium chloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name trospium chloride
Generic Name trospium chloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

trospium chloride 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-812
Product ID 71610-812_1523cfdd-99a0-6b9e-e063-6394a90afd3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204945
Listing Expiration 2026-12-31
Marketing Start 2015-11-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610812
Hyphenated Format 71610-812

Supplemental Identifiers

RxCUI
857560
UNII
1E6682427E

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 ANDA204945 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87)
source: ndc

Packages (1)

71610-812-87 2400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87)

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": "1523cfdd-99a0-6b9e-e063-6394a90afd3a", "openfda": {"unii": ["1E6682427E"], "rxcui": ["857560"], "spl_set_id": ["1523cb4c-3a52-6c18-e063-6394a90a396f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87)", "package_ndc": "71610-812-87", "marketing_start_date": "20240328"}], "brand_name": "Trospium Chloride", "product_id": "71610-812_1523cfdd-99a0-6b9e-e063-6394a90afd3a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "71610-812", "generic_name": "Trospium Chloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trospium Chloride", "active_ingredients": [{"name": "TROSPIUM CHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204945", "marketing_category": "ANDA", "marketing_start_date": "20151116", "listing_expiration_date": "20261231"}